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Legal Compliance & Regulatory Operations Manager (Mexico) at Telcoin

Leads compliance and regulatory operations for a fintech company in Mexico, managing licensing applications, AML/CFT programs, and regulatory strategy.

Senior Hybrid Posted about 7 hours ago RemoteFirstJobs Product
What this role involves

Position Title: Compliance & Regulatory Operations Manager (Mexico) Location: Mexico – Hybrid

Employment Type: Full-time

Reporting to: Country Manager, Mexico (solid line) / Global Chief Compliance Officer (dotted line)

Company Overview

Telcoin is a global fintech company focused on developing innovative financial products and infrastructure at the intersection of telecommunications, payments, and digital assets (Stablecoins).

Established in 2017, Telcoin operates through entities across multiple international markets and continues to expand its regulated financial services footprint.

As we develop our business in Mexico, we are seeking an experienced Compliance & Regulatory Operations Manager who can lead our local compliance function while also taking a hands-on role in regulatory applications, licensing initiatives, and broader business operations.

Role Overview

The Compliance & Regulatory Operations Manager will be a key member of Telcoin Mexico’s leadership team.

The role will have a solid-line reporting relationship to the Country Manager in Mexico, while maintaining a dotted-line relationship to Telcoin’s Global Chief Compliance Officer and working closely with Telcoin’s global Compliance, Legal, Product, Operations, Finance, and Risk teams.  This is a hands-on leadership role, not a purely advisory one. You will move between regulatory interpretation and practical execution: leading Telcoin’s financial institution application from preparation through regulatory review, owning the local AML/CFT program end to end, and acting as a trusted advisor to the Country Manager on how regulatory requirements shape the business, including virtual-assest-related obligations.  The person joining us should therefore be comfortable working in an environment where regulatory, operational, and commercial workstreams frequently overlap.

Key Responsibilities

Regulatory Strategy & Licensing

  • Work closely with the Country Manager, Global Chief Compliance Officer, Legal team, senior management, and external regulatory advisers to execute Telcoin’s regulatory strategy in Mexico.

  • Take a hands-on role in preparing regulatory applications, supporting documentation, policies, procedures, business plans, operating models, risk assessments, and responses to regulatory inquiries.

  • Support Telcoin’s planned application for authorization as an financial institution and help manage the application and authorization process from preparation through regulatory review.

  • Support other registrations and regulatory initiatives relevant to Telcoin’s business model, including:

    • SAT registration and ongoing obligations relating to Actividades Vulnerables involving virtual assets;
    • applicable CNBV registrations or authorizations;
    • additional financial-services permissions that may become necessary as the Mexican business develops.
  • Coordinate regulatory projects across Telcoin’s local and global teams and external advisers.

  • Track regulatory submissions, outstanding requirements, dependencies, deadlines, and regulator requests.

  • Serve as a key point of contact with Mexican regulators and governmental authorities where appropriate.

AML / CFT & Compliance Management

  • Develop, implement, maintain, and continuously improve Telcoin Mexico’s AML/CFT and financial-crime compliance framework.
  • Maintain local policies and procedures in accordance with Mexican law while ensuring appropriate alignment with Telcoin Group’s global compliance standards.
  • Conduct and maintain AML/CFT and other regulatory risk assessments applicable to the Mexican business.
  • Oversee customer due diligence, KYC, enhanced due diligence, beneficial ownership identification, sanctions screening, transaction monitoring, and related financial-crime controls.
  • Ensure required regulatory notices, reports, and other filings are submitted accurately and within applicable deadlines.
  • Review potentially suspicious customer or transactional activity and coordinate escalation and reporting processes where required.
  • Maintain appropriate compliance records, registers, evidence, and documentation.
  • Monitor regulatory developments in Mexico and assess their impact on Telcoin’s products and operations.
  • Work with the Global Compliance team to continuously strengthen Telcoin’s compliance framework and controls.
  • Support regulatory inspections, audits, information requests, and remediation programs.

Business & Regulatory Operations

This role will also act as a hands-on business partner to the Country Manager.

Responsibilities may include:

  • Supporting the Country Manager with regulatory, operational, and administrative requirements involved in establishing and scaling Telcoin’s Mexican business.
  • Helping translate regulatory requirements into practical product and operational processes.
  • Working with Product and Engineering teams to ensure regulatory requirements are appropriately incorporated into product development.
  • Coordinating with banks, payment partners, vendors, consultants, lawyers, auditors, and other third parties required to establish Telcoin’s operations.
  • Assisting with business applications, due diligence requests, questionnaires, banking relationships, vendor onboarding, and regulatory documentation.
  • Supporting the development of operating procedures and internal controls as the local organization grows.
  • Taking ownership of projects outside of traditional compliance responsibilities where necessary to help establish and grow the Mexican business.

We are looking for someone who is comfortable rolling up their sleeves and getting things done, rather than operating solely as a policy or advisory function.

Qualifications & Experience

Required

  • Bachelor’s degree in Law, Finance, Business Administration, Accounting, Economics, or a related field.
  • Significant professional experience in compliance, regulatory affairs, financial crime, legal/regulatory operations, or a closely related role within Mexico.
  • Strong practical knowledge of the Mexican financial-services regulatory environment.
  • Experience working with or interacting with Mexican regulators such as CNBV, SAT, SHCP/UIF, or Banco de MĂ©xico.
  • Practical experience with AML/CFT, KYC/CDD, transaction monitoring, regulatory reporting, and compliance controls.
  • Experience preparing regulatory documentation and coordinating complex regulatory or licensing projects.
  • Ability to independently manage projects involving multiple internal and external stakeholders.
  • Strong organizational and analytical skills with excellent attention to detail.
  • Commercial mindset and ability to understand how regulatory requirements affect products and business models.
  • Comfortable working in a fast-moving environment where processes and regulatory structures are still being built.
  • Professional fluency in Spanish and English.
  • Resident in Mexico.

Highly Desirable

  • Previous experience working for an Financial Institution fintech, payments company, digital asset company, bank, money transmitter, or other regulated financial institution in Mexico.
  • Direct experience supporting an Financial Institution authorization or another CNBV financial institution licensing process.
  • Experience establishing a compliance program or regulated operation from an early stage.
  • Knowledge of Mexican regulation relating to virtual assets and Actividades Vulnerables.
  • Experience working with cryptocurrency, blockchain, stablecoins, digital wallets, cross-border payments, or other digital financial products.
  • CNBV certification in PLD/FT/FPADM, or eligibility and willingness to obtain the applicable certification.
  • Experience working within an international organization and coordinating with global Compliance, Legal, Product, and Operations teams.

The Person We’re Looking For

The ideal candidate combines the mindset of a compliance professional, regulatory project manager, and business operator.

You should be comfortable interpreting regulation and discussing technical compliance requirements with lawyers and regulators, but equally comfortable opening a spreadsheet, preparing an application, coordinating documentation, working with a banking partner, reviewing a product workflow, or helping the Country Manager solve an operational problem.

Telcoin Mexico is entering an important stage of its development, including preparations for additional financial-services authorization. This role provides an opportunity to help build the regulatory and operational foundation of the business rather than simply maintain an established compliance program.

Application Process

Interested candidates should submit a resume outlining their relevant experience, particularly any experience involving Mexican financial-services regulation, AML/CFT, fintech, payments, digital assets, or regulatory licensing.

Please highlight any relevant professional certifications, including CNBV AML/CFT certification, and any direct experience with a financial institution authorization processes in Mexico.

Telcoin is an equal opportunity employer committed to diversity and inclusion in the workplace. We encourage qualified candidates from all backgrounds to apply.

Read the full description
Legal Counsel, Commercial at Snorkel AI

Drafts, reviews, and negotiates commercial contracts including vendor and customer agreements while serving as legal partner to cross-functional teams.

Mid Hybrid Posted 1 day ago RemoteFirstJobs Product
What this role involves

About Snorkel

At Snorkel, we believe meaningful AI doesn’t start with the model, it starts with the data.

We’re on a mission to help enterprises transform expert knowledge into specialized AI at scale. The AI landscape has gone through incredible changes since 2015, when Snorkel started as a research project in the Stanford AI Lab, to the generative AI breakthroughs of today. But one thing has remained constant: the data you use to build AI is the key to achieving differentiation, high performance, and production-ready systems. We work with some of the world’s largest organizations to empower scientists, engineers, financial experts, product creators, journalists, and more to build custom AI with their data faster than ever before. Excited to help us redefine how AI is built? Apply to be the newest Snorkeler!

Counsel, Commercial

What You’ll Do

Snorkel AI is looking for a Counsel, Commercial to join our growing Legal team, reporting to Snorkel’s Associate General Counsel, Commercial. This is a key role across Snorkel’s commercial contracting function, including vendor agreements and customer agreements.

You will serve as a trusted legal partner to business teams across the company, drafting, reviewing, and negotiating a wide range of commercial contracts while helping build scalable processes. You’ll work closely with cross-functional stakeholders, combining strong commercial legal skills with the hands-on, execution-oriented approach required in a fast-growing technology company.

This hybrid role is based in San Francisco or New York City.

Responsibilities

  • Draft, review, and negotiate a broad range of commercial contracts, including vendor and customer agreements, NDAs, MSAs, SOWs, order forms, and other commercial arrangements.
  • Serve as a trusted legal partner to cross-functional teams on commercial contracts.
  • Manage a high volume of contracts and competing priorities, ensuring timely execution and alignment with business objectives.
  • Review and negotiate commercial agreement efficiently and identity when issues require escalation or cross-functional input.
  • Contribute to the development and continuous improvement of contract templates, playbooks, and negotiation guidelines to drive consistency and efficiency across the commercial contracting process.
  • Manage contract workflows and lifecycle processes, including intake, routing, approval, execution, and archival.
  • Support the Associate General Counsel, Commercial on ad hoc legal projects and other matters as needed.

Who You Are

Minimum Qualifications

  • J.D. and active membership in good standing in at least one U.S. jurisdiction.
  • 3–5 years of relevant commercial or transactional legal experience in-house.
  • Strong experience drafting and negotiating a wide range of commercial contracts, including vendor agreements, customer agreements, NDAs, MSAs, SOWs, and order forms.
  • Excellent drafting, negotiation, and communication skills, with the ability to explain complex legal concepts clearly to business stakeholders.
  • Experience with Ironclad or similar contract lifecycle management (CLM) platforms.
  • Comfort with using AI workflows and operating in a fast-paced environment.
  • Strong business judgment and the ability to balance legal risk with business objectives in a fast-moving environment.
  • Ability to manage a high volume of contracts and competing priorities in a fast-moving environment.

Preferred Qualifications

  • Experience at a technology, AI company, or at a high-growth startup.
  • Experience helping build or improve contracting workflows, templates, or vendor review processes.
  • Comfortable operating in a fast-moving environment where priorities evolve and the Legal team is expected to be both strategic and highly execution-oriented.

Actual compensation will be determined based on factors including skills, qualifications, experience, and geographic location.

Salary range(s) for this role

$125,000—$185,000 USD

Be Your Best at Snorkel

Joining Snorkel AI means becoming part of a company that has market proven solutions, robust funding, and is scaling rapidly—offering a unique combination of stability and the excitement of high growth. As a member of our team, you’ll have meaningful opportunities to shape priorities and initiatives, influence key strategic decisions, and directly impact our ongoing success. Whether you’re looking to deepen your technical expertise, explore leadership opportunities, or learn new skills across multiple functions, you’re fully supported in building your career in an environment designed for growth, learning, and shared success.

Snorkel AI is proud to be an Equal Employment Opportunity employer and is committed to building a team that represents a variety of backgrounds, perspectives, and skills. Snorkel AI embraces diversity and provides equal employment opportunities to all employees and applicants for employment. Snorkel AI prohibits discrimination and harassment of any type on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local law. All employment is decided on the basis of qualifications, performance, merit, and business need.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Read the full description
Legal Counsel, Commercial at Snorkel AI

Drafts, reviews, and negotiates commercial contracts including vendor and customer agreements while building scalable legal processes for a fast-growing AI company.

Mid Hybrid Posted 1 day ago RemoteFirstJobs Product
What this role involves

About Snorkel

At Snorkel, we believe meaningful AI doesn’t start with the model, it starts with the data.

We’re on a mission to help enterprises transform expert knowledge into specialized AI at scale. The AI landscape has gone through incredible changes since 2015, when Snorkel started as a research project in the Stanford AI Lab, to the generative AI breakthroughs of today. But one thing has remained constant: the data you use to build AI is the key to achieving differentiation, high performance, and production-ready systems. We work with some of the world’s largest organizations to empower scientists, engineers, financial experts, product creators, journalists, and more to build custom AI with their data faster than ever before. Excited to help us redefine how AI is built? Apply to be the newest Snorkeler!

Counsel, Commercial

What You’ll Do

Snorkel AI is looking for a Counsel, Commercial to join our growing Legal team, reporting to Snorkel’s Associate General Counsel, Commercial. This is a key role across Snorkel’s commercial contracting function, including vendor agreements and customer agreements.

You will serve as a trusted legal partner to business teams across the company, drafting, reviewing, and negotiating a wide range of commercial contracts while helping build scalable processes. You’ll work closely with cross-functional stakeholders, combining strong commercial legal skills with the hands-on, execution-oriented approach required in a fast-growing technology company.

This hybrid role is based in San Francisco or New York City.

Responsibilities

  • Draft, review, and negotiate a broad range of commercial contracts, including vendor and customer agreements, NDAs, MSAs, SOWs, order forms, and other commercial arrangements.
  • Serve as a trusted legal partner to cross-functional teams on commercial contracts.
  • Manage a high volume of contracts and competing priorities, ensuring timely execution and alignment with business objectives.
  • Review and negotiate commercial agreement efficiently and identity when issues require escalation or cross-functional input.
  • Contribute to the development and continuous improvement of contract templates, playbooks, and negotiation guidelines to drive consistency and efficiency across the commercial contracting process.
  • Manage contract workflows and lifecycle processes, including intake, routing, approval, execution, and archival.
  • Support the Associate General Counsel, Commercial on ad hoc legal projects and other matters as needed.

Who You Are

Minimum Qualifications

  • J.D. and active membership in good standing in at least one U.S. jurisdiction.
  • 3–5 years of relevant commercial or transactional legal experience in-house.
  • Strong experience drafting and negotiating a wide range of commercial contracts, including vendor agreements, customer agreements, NDAs, MSAs, SOWs, and order forms.
  • Excellent drafting, negotiation, and communication skills, with the ability to explain complex legal concepts clearly to business stakeholders.
  • Experience with Ironclad or similar contract lifecycle management (CLM) platforms.
  • Comfort with using AI workflows and operating in a fast-paced environment.
  • Strong business judgment and the ability to balance legal risk with business objectives in a fast-moving environment.
  • Ability to manage a high volume of contracts and competing priorities in a fast-moving environment.

Preferred Qualifications

  • Experience at a technology, AI company, or at a high-growth startup.
  • Experience helping build or improve contracting workflows, templates, or vendor review processes.
  • Comfortable operating in a fast-moving environment where priorities evolve and the Legal team is expected to be both strategic and highly execution-oriented.

Actual compensation will be determined based on factors including skills, qualifications, experience, and geographic location.

Salary range(s) for this role

$125,000—$185,000 USD

Be Your Best at Snorkel

Joining Snorkel AI means becoming part of a company that has market proven solutions, robust funding, and is scaling rapidly—offering a unique combination of stability and the excitement of high growth. As a member of our team, you’ll have meaningful opportunities to shape priorities and initiatives, influence key strategic decisions, and directly impact our ongoing success. Whether you’re looking to deepen your technical expertise, explore leadership opportunities, or learn new skills across multiple functions, you’re fully supported in building your career in an environment designed for growth, learning, and shared success.

Snorkel AI is proud to be an Equal Employment Opportunity employer and is committed to building a team that represents a variety of backgrounds, perspectives, and skills. Snorkel AI embraces diversity and provides equal employment opportunities to all employees and applicants for employment. Snorkel AI prohibits discrimination and harassment of any type on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local law. All employment is decided on the basis of qualifications, performance, merit, and business need.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Read the full description
Legal Deputy Director of Government Affairs - Hybrid Sacramento CA at California Primary Care Association

Analyzes legislative and regulatory proposals, develops advocacy strategies, and represents the organization before California lawmakers and budget committees.

Senior Hybrid Posted 4 days ago RemoteFirstJobs Product
What this role involves

Please Note: If you viewed this position through a job board (LinkedIn, Indeed, ZipRecruiter, etc.) and are looking to apply, please do so by viewing our open jobs on our website: CPCA Employment Opportunities.

Association’s Mission:

California Primary Care Association’s (CPCA’s) mission is to lead and position community clinics, health centers and networks through advocacy, education, and services as key players in the health care delivery system to improve the health status of their communities.

Purpose of the Position:

CPCA and its affiliate, CPCA Advocates (Advocates), are statewide leaders in advancing policies that support community health centers, expand access to care, promote health equity, and strengthen California’s health care delivery system.

The Deputy Director of Government Affairs helps position CPCA and Advocates as leading voices on health care policy before the California Legislature and Administration. This position plays an active role in legislative and budget advocacy efforts by analyzing policy proposals, developing advocacy strategies, communicating legislative priorities to policymakers and members, building and maintaining strategic relationships, participating in coalitions, and representing Advocates before legislative and budget committees. The Deputy Director also supports the development of CPCA’s legislative priorities, public policy principles, and advocacy initiatives that advance community health centers and health equity throughout California.

Primary Responsibilities:

Legislative Advocacy & Policy

  • Research, analyze, and track legislative and regulatory proposals affecting community health centers, health care access, and CPCA policy priorities.
  • Assess proposed legislation and regulations, develop recommendations consistent with CPCA policy, and support the development and implementation of legislative and budget advocacy strategies.
  • Draft position letters, legislative correspondence, talking points, testimony, and other advocacy materials.
  •  Represent Advocates at legislative and budget hearings and communicate timely legislative and regulatory updates to CPCA leadership, members, committees, and stakeholders.
  • Support the development of CPCA’s public policy principles and legislative priorities.

Legislative & Government Relationships

  • Develop and maintain effective working relationships with legislators, legislative staff, state officials, CPCA leaders, members, and other government affairs stakeholders.
  • Meet with legislators and legislative staff to communicate CPCA priorities and advocate for policy positions.
  • Develop expertise in assigned policy areas and serve as a resource to CPCA staff and members.

Coalition Building & Advocacy Strategy

  • Develop and maintain coalitions and strategic partnerships in support of CPCA legislative priorities.
  • Coordinate advocacy strategies with coalition partners and identify opportunities to advance CPCA policy priorities.
  • Collaborate with advocacy, communications, grassroots, and policy partners to support legislative and advocacy efforts.

Member & Internal Engagement

  • Communicate legislative and regulatory developments to CPCA members, committees, and other stakeholders through written materials, presentations, meetings, and other forums.
  • Staff CPCA committees, workgroups, task forces, peer networks, and other governance bodies as assigned.
  • Collaborate with CPCA departments to support advocacy, communications, grassroots engagement, and organizational alignment.

Organizational Leadership

  • Engage in Advocates activities in collaboration with the Vice President of Government Affairs and the Director of Government Affairs and Political Engagement.
  • Manage multiple legislative and policy assignments while meeting deadlines in a fast-moving legislative environment.
  • Take ownership of assigned policy areas and progressively develop independent expertise and responsibility.

Additional Responsibilities:

  • Support the Association’s Strategic Plan
  • Respond promptly and thoroughly to member inquiries.
  • Assist with grant and budget management, contract development and reporting.
  • Serve as lead staff to designated peer networks, work groups, task forces and committees.
  • Serve as a subject‑matter resource, providing guidance and sharing expertise with team members.
  • High levels of interaction with association members, vendors, and strategic partners.
  • Travel for national and regional meetings, trainings, and site visits by air and ground transportation, as required.
  • Report regularly to supervisor.

Skills and Abilities Required:

  • Ability to quickly understand complex legislative and policy issues and communicate their importance clearly and persuasively.
  • Strong written and oral communication skills.
  • Ability to develop and maintain effective professional relationships for advocacy purposes.
  • Ability to manage multiple assignments with minimal supervision.
  • Strong problem-solving, critical-thinking, organizational, and time-management skills.
  • Ability to work collaboratively with senior leadership and multidisciplinary teams.
  • Strong interpersonal and professional skills when engaging with Association members, the Board of Directors, vendors, partners, legislators, legislative staff, and government officials.
  • Ability to develop a high level of expertise in assigned policy areas and provide guidance and technical assistance to CPCA staff and members.
  • Proficiency in Microsoft Office and web-based applications and platforms.

Education and Experience:

Bachelor’s degree and a minimum of five years of experience in legislative affairs, government relations, public policy, advocacy, political engagement, public affairs, or a related field. Relevant experience may be substituted for the degree requirement.

Preferred Experience:

  • Experience working with the California Legislature or California state government.
  • Experience in California healthcare policy and an understanding of the impact of federal policy on healthcare issues.
  • Experience with community health centers, membership associations, or nonprofit organizations is also preferred.

Compensation : $118,959 - $125,957

Why You’ll Love Working Here:

  • Hybrid work schedule (2 days in the office weekly, with an additional in-office day once per month)
  • 100% employer-paid medical, dental, vision, life, and AD&D insurance
  • 5% employer retirement contribution
  • Generous paid time off: 15 vacation days, 12 sick days, 2 floating holidays, plus 18 paid holidays (including a December 24th - January 1st Winter Break)
  • Monthly stipends: $50 for cell phone and $50 for internet
  • Parking benefits
  • Employee Assistance Program (EAP) and voluntary benefits, including pet insurance, Aflac, and FSA options

Association Expectation:

Due to network security and hybrid work this position requires the employee to have a cell phone with a data plan and home internet service, both are reimbursed at a set rate each month. All hires are required to maintain residence in California. This is a hybrid position with employees coming into the office in downtown Sacramento.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Hearing and speaking to exchange information
  • Operating a computer and other office productivity equipment
  • Seeing to read a variety of materials
  • Bending at the waist, kneeling, or crouching
  • Sitting or standing for extended periods of time
  • Lifting objects up to 30 pounds
  • Close vision and ability to adjust focus

Work Environment:

  • Noise level is generally moderate, but at times can be noisy
  • Meetings conducted in a Zoom or office setting
  • Indoor varying temperature
  • Employee must have available transportation and be able to commute into office

Equal Opportunity Employment:

CPCA’s workforce strives to represent California’s population, while also meeting the highest standards and qualifications of our industry.

Read the full description
Legal Paralegal Intern at Catawiki

Paralegal trainee supports international legal team across commercial, compliance, and corporate law matters while maintaining case management systems and drafting legal memos.

Junior Hybrid Posted 12 days ago RemoteFirstJobs Product
What this role involves

At Catawiki, every day brings the extraordinary! Whether it’s Daniel Ricciardo’s Formula 1 Car, a Woolly Mammoth’s Skeleton, Lady Gaga’s Jumpsuit or Usain Bolt’s running shoe, we encounter exceptional objects every day.

We’re a one-of-a-kind marketplace for buying and selling special objects. Each week, more than 100,000 unique items are auctioned, all carefully curated by our passionate in-house experts.

Having sold over 25 million unique objects, our mission is to become the world’s most popular destination for special objects. As a growing, diverse and sustainable scale-up, we proudly live by three core values. If these values resonate with you, we’d love to explore how you can join us.

  • Taking ownership and driving impact
  • Being open to change and feedback
  • Being passionate about our mission and our customers.

The role

As a Trainee/Paralegal, you will be an important part of the Catawiki legal team and as such support the international business in its ambitious growth targets. You are passionate about providing support to legal counsels at the best possible level. As you will be involved in a very wide range of legal projects, this role will give you the opportunity to see, practice, and learn a lot. The legal fields include commercial law, consumer law, contract law, compliance, privacy, data protection, corporate law, sustainability/ESG and last but not least artificial intelligence. No day is like the other - The work is varied, the business is dynamic, so each day is a new challenge!

This is a role for a traineeship with a fixed term of 6 months in which you will get the opportunity to grow and help a wide range of people and as such you know how to relate to people in a variety of situations because you are a team player, highly trustworthy, discrete, pragmatic and make use of your good judgement.

Within and outside your circle of influence you are expected to proactively come up with solutions, plans, and ideas that enable the legal team to achieve its ambitious goals.

The Catawiki legal team is based at the company headquarter in Amsterdam. We use a hybrid work schedule, with on average two office days a week (Tuesday & Thursday).

Results and Responsibilities

  • Supporting legal operations and maintaining the case management system
  • Support in the further development of the contract management system and any other legal or compliance tooling
  • Drafting internal memos on specific relevant legal, regulatory or compliance topics
  • Monitoring and reporting on several legal dashboard(s)
  • Reviewing and addressing legal questions raised by other departments
  • Taking notes during regular project meetings and sharing them afterwards, keeping track of deadlines and deliverables
  • Prepare simple training materials and legal guidelines for our business stakeholders, with support of the legal counsels
  • Further develop and update the Legal Knowledge Hub, including links to templates, guidelines, do’s & don’ts; and updating current content in alignment with the legal counsels

Tasks and Activities

  • Support the legal counsels in their daily tasks
  • Dealing with the review of standard agreement such as NDA’s and commercial contracts
  • Contract and litigation administration management
  • Ensure further professionalism of the department by inventorying, implementing and optimising tools, documents and processes
  • Understand improvement needs and provide support to team members
  • Communicate expectations to your team and provide timely updates
  • You are actively seeking and driving collaboration with other teams and other departments
  • You are proactively liaising with (international) stakeholders and colleagues at Catawiki
  • Support corporate housekeeping by coordinating that documents are duly signed, apostilled and notarized in a timely manner
  • Compilation and implementation of a wide variety of legal documents and agreements
  • Provide assistance in helping to resolve legal matters as requested

Requirements

  • Enrolled in a Dutch University for the whole duration of the next academic year
  • Thesis writing is not supported during the initial six-month period, but may be an option upon contract extension
  • This is a traineeship with a non-negotiable minimum duration of 6 months, preferably 1 year but not mandatory
  • Certification or associate’s degree in law (bachelor’s degree is preferred) (or final stage)
  • Tech savvy
  • Experience in preparing and reviewing legal documents
  • “Can do” and “hands on” mentality
  • Team player
  • Strong organisational and communication skills
  • Fluency in English, preferred fluency in Dutch (proficiency in any other language is a plus)
  • Residency in the Netherlands and able to go to our Amsterdam office twice per week

Why You’ll Love Working with Us

  • Create a visible impact by working at scale in a global organisation serving millions of customers across 80+ categories. In our flat structure, every role has a broad scope and directly impacts both our customers and the business.
  • Learn and grow through our Learning & Development initiatives, including clear development plans and mentorship programmes to support your career progression.
  • A culture of connection defines us. We’re a passionate, diverse team of 800+ Catawikians representing 60+ nationalities. We foster an inclusive and queer-friendly environment where everyone is encouraged to bring their full self to work.
  • Celebrate life’s moments with us. You’ll receive a €100 Catavoucher when you join, a €50 Catavoucher on your birthday, and an extra day off each year to “Pursue Your Passion ”. We also offer additional leave for key work anniversaries and important life events. Benefits may vary by location.

Our Offices and Way of Working

Our vibrant offices in Amsterdam and Lisbon are designed to inspire collaboration. Most Catawikians operate in a hybrid setup, combining office-based and remote work, with a minimum of two days per week in the office, unless a role is explicitly stated as fully remote or fully office-based.

Interested?

Apply with an English CV and Cover Letter. By applying, you agree to Catawiki’s Applicant Privacy Policy. If you’re excited about this role but don’t meet every requirement, we still encourage you to apply anyway. You may be just the right candidate for this or other roles.

Read the full description
Legal Associate Director, International Regulatory Affairs Advertising & Promotion-Hybrid at AbbVie

Oversees international regulatory compliance for pharmaceutical advertising and promotion, ensuring adherence to global regulatory standards and developing strategies across marketed and development products.

Lead Hybrid Posted 26 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Associate Director, International Regulatory Affairs Advertising & Promotion safeguards products and practices to adhere to the highest quality and regulatory standards. The Associate Director will be responsible for the implementation of regulatory advertising and promotion strategies for marketed and development compounds in alignment with the overarching global regulatory strategy and global brand plan and leads the international regulatory strategy for the assigned marketed and development compounds. The Associate Director will interface with International Marketing, International Medical Affairs, Global Legal and Office of Ethics and Compliance with regard to advertising and promotion strategies and tactics intended for use globally.

Responsibilities:

  • Reviews and evaluates the global industry environment (e.g., regulatory, legal, and political climate) and plans strategically for overall system of regulatory communications. Provides functional input on key initiatives impacting other areas. Leads the implementation of risk management strategies and risk management plans for global Regulatory advertising and promotion.
  • Provides global regulatory position, perspective, and expertise related to advertising and promotion to internal and external customers/business partners. Maintains current knowledge of global codes of practice, regulations and guidance’s that impact pharmaceutical advertising and promotion. Has direct international (ex-US) accountability for assigned therapeutic areas within the Regulatory Advertising and Promotion department.
  • Implements department policies and procedures and significantly contributes to the development and updates to Divisional and Corporate policies effecting global core messaging. Supports departmental and business strategies, quality initiatives, compliance with policies and procedures, and the implementation of improvement plans. Contributes to the evaluation of departmental needs and implements solutions to enhance and facilitate operations.
  • Provides critical analysis and potential interpretations of the regulatory position and messaging for communications in response to often highly visible pharmaceutical news having political, financial and legal interests. Creates an environment to attract, retain, empower and mentor leaders in business knowledge, management skills, and continued development. Provides strategic input into comprehensive training program. Negotiates/resolves the majority of decisions with Marketing, Medical, Legal, Public Affairs, and compliance counterparts.
  • Collaborates and communicates effectively through all levels of management across multiple divisions and functions. Is recognized by organizational counterparts as a key company resource on pharmaceutical advertising and promotion. Apply novel and creative methods to problem solving. Constantly searches for out of the box solutions while maintaining quality and adherence to regulations.
  • Balances business needs and risk assessments with creative decision-making abilities. Responsible for assigned marketed and development compounds advertising and promotion strategies. Has accountability for: the sound representation of global Regulatory Advertising and Promotion position within and external to AbbVie; and the operations, initiatives, and strategies for the regulatory Advertising and Promotion department.
  • Leads cross-functional/ multidisciplinary/therapeutic teams Demonstrates compliance with international codes of practice relevant regulations and manages financial business goals.
  • This role is required to work a hybrid work schedule-3 days in office from our AbbVie Mettawa, IL headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Minimum bachelor’s degree (or equivalent) in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), is required. Master’s, Ph.D or Pharm D preferred.
  • You should also possess:
    • Associate Director: 8+ years of pharmaceutical experience with a Bachelor’s, 5+ years with a Pharm D plus relevant ad promo experience
  • The candidate must have a solid understanding of regulatory advertising and promotion regulations, having had direct responsibility in this area.
  • International experience desired but not required

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager RA US Advertising and Promotion - Hybrid at AbbVie

Manages regulatory affairs for pharmaceutical advertising and promotion, ensuring compliance with FDA regulations while overseeing team development and policy analysis.

Senior Hybrid Posted 27 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

  • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
  • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
  • Summarizes findings, under supervision, in concise reports for distribution within AbbVie
  • Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
  • Development and guides implementation strategies for promotional activities
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
  • Effectively presents pertinent information to appropriate cross-functional groups.
  • Effectively delivers difficult messages to commercial organizations without damage to relationships
  • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
  • This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
  • Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Experience working in a complex and matrix environment and exhibits strong negotiation skills
  • Strong communication skills, both oral and written
  • Experience in management capacity preferred
  • Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Associate Regulatory Affairs Submission Management - Hybrid at AbbVie

Manages regulatory submission projects and timelines for pharmaceutical dossiers, coordinating cross-functional teams and vendor publishing to meet regulatory authority requirements.

Senior Hybrid Posted 27 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Associate, Regulatory Affairs Submission Management, manages medium to high impact, moderately complex submission projects involving multiple cross-functional regulatory submission teams. With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as very knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities:

  • Manages medium to high impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
  • Acts as RA Submissions interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.
  • Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
  • Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks
  • May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
  • Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
  • Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in moderately complex submissions. Facilitates team reviews.
  • Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
  • Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
  • Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
  • Contributes to the creation, and implementation of internal process and standards documents relating to publishing and publishing deliverables.
  • Position accountability/scope:
    • Some supervision required
    • Receives project assignments from manager but has responsibility for managing own projects with some oversight
    • Reviews project progress with manager on a regular basis with direction provided by manager
    • Trains, and mentors less experienced staff.
  • This position will work a hybrid work schedule, 3 days in office & 2 days remote, from our AbbVie North Chicago, IL headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Required Education: Bachelor’s degree.
    • Note: Years of experience may also compensate for lower education.
    • Preferred Education: PMP and RAC certificates a plus
  • Required Experience: Four years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat.
  • Preferred Experience:
    • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
    • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
    • Proven leadership skills and presence
    • NOTE: Higher education may compensate for years of experience.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors  including  geographic location, and we may ultimately  pay more or less than the posted range. This range may be  modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to  participate in our short-term incentive programs.  ​

Note: No amount of pay is  considered to be wages or compensation until such amount is earned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a   particular employee  remains in the Company’s sole and absolute discretion unless and until paid and may be  modified at the Company’s sole and absolute discretion,  consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager RA US Advertising and Promotion - Hybrid at AbbVie

Manages regulatory compliance for pharmaceutical advertising and promotion while supervising regulatory staff and monitoring government policy changes affecting the organization.

Lead Hybrid Posted 27 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

  • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
  • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
  • Summarizes findings, under supervision, in concise reports for distribution within AbbVie
  • Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
  • Development and guides implementation strategies for promotional activities
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
  • Effectively presents pertinent information to appropriate cross-functional groups.
  • Effectively delivers difficult messages to commercial organizations without damage to relationships
  • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
  • This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
  • Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Experience working in a complex and matrix environment and exhibits strong negotiation skills
  • Strong communication skills, both oral and written
  • Experience in management capacity preferred
  • Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Manager, Regulatory Affairs Submission Management - Hybrid at AbbVie

Manages complex regulatory submission projects across cross-functional teams, coordinating timelines, publishing, and compliance with regulatory authority specifications.

Mid Hybrid Posted 27 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Manager, Regulatory Affairs Submission Management, manages high impact, complex submission

projects involving multiple cross-functional regulatory submission teams. With input from the submission

teams, this individual establishes and maintains submission content planners and associated timelines,

facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with

publishing vendor, and fulfills Submission Management functions on Project Teams in support of

Development, Marketing, and post-marketing regulatory authority applications. The Manager is recognized

as a discipline expert and resource in regulatory affairs submission management.

Responsibilities:

  • Independently manages high impact (with respect to internal visibility, risk, complexity and criticality)submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
  • Acts as primary RA Submissions interface with project teams providing guidance and communication of established submission processes, standards and technical specifications. Plans and negotiates submission project scope, publishing timelines and deliverables.
  • Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
  • Coordinates submission publishing with offsite publishers/provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks.
  • May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support. Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.  Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
  • Facilitates team reviews and ensures detailed quality reviews of published output are completed per current standards to ensure compliance with Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in complex submissions.
  • Actively contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions. Creates, implements, and finalizes internal process and standards documents relating to publishing and publishing deliverables.
  • Suggests and implements process improvements. May recommend changes to software and business processes to support changes in regulations that support complex submissions May lead or participate on internal project teams to update business software.
  • Position accountability/scope: o
    • Minimal supervision required o Receives project assignments from manager but has responsibility for managing own projects.
    • Reviews project progress with manager on a regular basis with direction provided on follow-up.
    • Provides estimates of activities with budgetary impact.
    • Trains, mentors and may supervise the work of less experienced staff.
  • Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Required Education: Bachelor’s degree.
    • Note: Years of experience may also compensate for lower education.
    • Preferred Education: PMP and RAC certificates a plus
  • Required Experience: 6 years’ pharmaceutical or industry related experience with publishing related software tools e.g. Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, Adobe Acrobat. One to two years in cross functional project management.
  • Preferred Experience:
    • Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area
    • Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
    • Proven leadership skills and presence
    • NOTE: Higher education may compensate for years of experience.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
  • This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description
Legal Senior Manager RA US Advertising and Promotion - Hybrid at AbbVie

Senior regulatory affairs manager ensures pharmaceutical advertising and promotion materials comply with FDA regulations, manages regulatory staff, and monitors policy changes affecting the company.

Senior Hybrid Posted 27 days ago RemoteFirstJobs Product
What this role involves

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs US Advertising and Promotion-Immunology combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet the required legislation. Additionally, the individual develops and supervises regulatory professionals as needed. Supports the Director in efforts to influence the regulatory environment. The Senior Manager has department/group/site level influence and is generally recognized as an expert and resource and leads the department as a subject matter expert (SME) for Regulatory. This individual share knowledge and expertise with others in support of team activities and analyzes broad scope implications of changing regulations and policies.

Responsibilities:

  • Proactively captures and disseminates activities of government, industry, and trade associations that impact pharmaceutical regulatory policies relative to AbbVie’s interests. Maintains awareness of pending changes to communicate impact and relevance within Regulatory Operations. Drafts and finalizes comments in a timely manner, to regulators and trade associations. Distributes proposed policies to SMEs. Highlights key points in a clear and concise manner.
  • Represents department and participates in trade associations as needed. Develops good working relationships with trade association managers.
  • Summarizes findings, under supervision, in concise reports for distribution within AbbVie
  • Oversee the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies. Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the FDA and cosmetic Act.
  • Development and guides implementation strategies for promotional activities
  • Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
  • Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs related to advertising and promotion regulations for self and direct reports. Manages direct reports and assists in the development, training and mentoring of staff members
  • Effectively presents pertinent information to appropriate cross-functional groups.
  • Effectively delivers difficult messages to commercial organizations without damage to relationships
  • Establishes solid relationships with management and key stakeholders (Marketing, Medical, Clinical, Legal, Sales Training, Managed Care, Public Affairs, etc.) fostering mutually beneficial interactions and exchange.
  • This role will work a hybrid work schedule (3 days in office & 2 days remotely) from one of the following AbbVie headquarters; Lake County, IL; Florham Park, NJ; Irvine, CA
  • Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

  • Minimum: Bachelor’s degree in science (biology, chemistry, microbiology immunology, medical technology, pharmacy, pharmacology, nursing, pharmacy) plus 7 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Preferred PharmD degree plus 5 years of relevant industry experience (e.g. regulatory affairs fellowship, Health Authority, ad promo, etc.)
  • Experience working in a complex and matrix environment and exhibits strong negotiation skills
  • Strong communication skills, both oral and written
  • Experience in management capacity preferred
  • Experience in US Regulatory Affairs Advertising and Promotion

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  • This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Read the full description