Director of Global Regulatory Affairs Jobs
Director of Global Regulatory Affairs jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer health, at every level from senior manager to VP, with specializations in drug approval strategy, international submissions, and compliance program leadership. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 60+ Director of Global Regulatory Affairs jobs
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. In some instances, the Director of GL may also take on the role of Team Lead for a therapeutic area (TA), overseeing Labeling Project Leads (LPLs) working on products within that TA and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising and Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and also driving forward global labeling initiatives.
Location Classification – Hybrid:
This role will be required to work onsite 3 days a week (Tuesday - Thursday) or more depending on business needs. #LI-Hybrid
Key Accountabilities:
- Lead the development, review, approval, and implementation process for CCDSs, USPIs, EU SmPCs and labeling documents with cross-functional labeling teams. Prepare for senior management (LDB) review and approval.
- Ensure all labeling is scientifically accurate and meets the needs of healthcare professionals and patients.
- Provide tactical guidance to labeling teams regarding the labeling process, and regulatory requirements including application to product labeling content.
- Disseminate labeling for implementation in the US/EU and support country regulatory affairs in implementation changes locally.
- Support products in development by providing input into investigational brochures, development safety update reports and integrated evidence planning. In some cases, develop regulatory labeling strategy and content for products in development (i.e., target product label) with subject matter experts.
- Maintain expertise regarding key labeling requirements worldwide and stay updated with FDA/EMA labeling guidelines and regulations.
- Participate in labeling negotiations with agencies resulting in product approvals or labeling updates.
- In collaboration with department head, develop and periodically review labeling policies and standards. Provide guidance, and in some cases, drive process improvement initiatives.
- Support audits and CAPA resolutions.
- Represent labeling on cross-functional leadership programs and advisory boards.
Minimum Qualifications:
- Bachelor’s degree in science or health-related discipline
- 8+ years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs Labeling experience
- Deep knowledge and application of labeling requirements in the US/EU
- Experience managing labeling personnel and/or teams
Preferred Qualifications:
- Advanced degree (PhD, MD, MS, PharmD, MBA)
- Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project), SharePoint and regulatory systems (e.g., EDMS)
- Meticulous in reviewing regulatory documents for accuracy, consistency, and compliance
- Excellent written and oral communication skills
- Knowledge and application of labeling requirements in global countries including Japan and China
- Knowledge of global drug‐development and life‐cycle management regulations
Compensation & Benefits:
The expected salary range for this position is $182,100 - 273,100. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Work Your Magic with us! Start your next chapter and join EMD Serono.
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. In some instances, the Director of GL may also take on the role of Team Lead for a therapeutic area (TA), overseeing Labeling Project Leads (LPLs) working on products within that TA and fostering strong collaborations with TA leadership. Additionally, the Director of GL assists the Head of Labeling and Advertising and Promotion in preparing for and facilitating interactions with the Labeling Decision Board (LDB), and also driving forward global labeling initiatives.
Location Classification – Hybrid:
This role will be required to work onsite 3 days a week (Tuesday - Thursday) or more depending on business needs. #LI-Hybrid
Key Accountabilities:
- Lead the development, review, approval, and implementation process for CCDSs, USPIs, EU SmPCs and labeling documents with cross-functional labeling teams. Prepare for senior management (LDB) review and approval.
- Ensure all labeling is scientifically accurate and meets the needs of healthcare professionals and patients.
- Provide tactical guidance to labeling teams regarding the labeling process, and regulatory requirements including application to product labeling content.
- Disseminate labeling for implementation in the US/EU and support country regulatory affairs in implementation changes locally.
- Support products in development by providing input into investigational brochures, development safety update reports and integrated evidence planning. In some cases, develop regulatory labeling strategy and content for products in development (i.e., target product label) with subject matter experts.
- Maintain expertise regarding key labeling requirements worldwide and stay updated with FDA/EMA labeling guidelines and regulations.
- Participate in labeling negotiations with agencies resulting in product approvals or labeling updates.
- In collaboration with department head, develop and periodically review labeling policies and standards. Provide guidance, and in some cases, drive process improvement initiatives.
- Support audits and CAPA resolutions.
- Represent labeling on cross-functional leadership programs and advisory boards.
Minimum Qualifications:
- Bachelor’s degree in science or health-related discipline
- 8+ years of relevant pharmaceutical industry experience with 5+ years of relevant Regulatory Affairs Labeling experience
- Deep knowledge and application of labeling requirements in the US/EU
- Experience managing labeling personnel and/or teams
Preferred Qualifications:
- Advanced degree (PhD, MD, MS, PharmD, MBA)
- Advanced proficiency with MS Office (Word, Excel, PowerPoint, Project), SharePoint and regulatory systems (e.g., EDMS)
- Meticulous in reviewing regulatory documents for accuracy, consistency, and compliance
- Excellent written and oral communication skills
- Knowledge and application of labeling requirements in global countries including Japan and China
- Knowledge of global drug‐development and life‐cycle management regulations
Compensation & Benefits:
The expected salary range for this position is $182,100 - 273,100. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Director of Global Regulatory Affairs Jobs by Experience Level
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Find JobsDirector of Global Regulatory Affairs Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Consulting & Professional Services
What Employers Look For
The qualifications that appear most often in director of global regulatory affairs jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, or a related field
- Ten or more years of regulatory affairs experience across multiple health authorities
- Proven leadership of global regulatory submissions including CTD and eCTD formats
- Deep knowledge of FDA, EMA, and ICH guidelines and regulatory frameworks
- Experience managing regulatory teams and cross-functional stakeholder relationships
- RAC certification from the Regulatory Affairs Professionals Society preferred
Tips for Your Director of Global Regulatory Affairs Job Search
Tailor your resume for submission types
Hiring managers scan for the specific submission frameworks you've led, whether that's IND, NDA, BLA, CTD, or IMPD filings. Name the submission types, regions, and health authorities you've worked with directly rather than describing regulatory work in general terms.
Highlight your international authority relationships
Many postings prioritize candidates with direct experience engaging the FDA, EMA, PMDA, or Health Canada. Call out the specific agencies you've presented to or negotiated with, because that specificity tells employers whether your network maps to their pipeline.
Apply early to roles that fit
Migrate Mate lists director of global regulatory affairs openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Target companies by pipeline stage
A company in Phase III trials needs a director who can run a pre-NDA meeting, while a commercial-stage company needs someone managing post-approval commitments and label changes. Matching your experience to the company's current regulatory moment makes your application far more relevant.
Prepare a cross-functional influence story
Interviewers for director-level roles test whether you can align clinical, CMC, and commercial teams around a regulatory strategy. Walk into interviews ready to describe a specific situation where you resolved a cross-functional disagreement that affected a submission timeline.
Negotiate scope before you negotiate compensation
Before accepting an offer, clarify which geographies, product lines, and health authority relationships fall under your remit. The scope of a director of global regulatory affairs role varies enormously between companies, and misaligned expectations at this level are hard to unwind after you start.
Director of Global Regulatory Affairs Jobs: Frequently Asked Questions
Which companies are hiring the most director of global regulatory affairss?
The companies hiring the most director of global regulatory affairss right now include AbbVie, Takeda Pharmaceuticals, and Revolution Medicines, with the largest share of openings in Massachusetts, California, and New Jersey, based on current listings on Migrate Mate as of November 2026. Pharmaceutical and medical device companies at mid-to-late clinical stages tend to post the highest volume of director-level openings.
How many director of global regulatory affairs jobs are remote?
About 73% of director of global regulatory affairs openings are fully remote or hybrid as of November 2026, with the highest remote share in roles focused on regulatory strategy, agency submissions, and policy development rather than those requiring on-site lab or manufacturing oversight.
How do you become a director of global regulatory affairs?
Most directors of global regulatory affairs start with a degree in a life science, pharmacy, or engineering discipline, then spend years in regulatory coordinator or specialist roles building submission experience across product types and health authorities. Earning RAC certification signals formal competency, while taking on cross-functional project leadership, managing direct reports, and running interactions with agencies like the FDA or EMA builds the profile that director-level postings require.
Can you get hired as a director of global regulatory affairs with limited experience?
Moving directly into a director of global regulatory affairs role with minimal experience is rare, but candidates from adjacent backgrounds can accelerate their path. Someone with strong experience as a regulatory affairs manager who has led at least one major submission end-to-end and managed a small team is a realistic candidate at smaller biotech firms, which often promote from within or hire from outside their size tier when speed matters more than seniority.
What does the director of global regulatory affairs interview process look like?
The process typically begins with a recruiter screen focused on submission history and leadership scope, followed by a panel interview with VP-level regulatory and clinical leaders who probe your agency interaction experience and strategic judgment. Many companies add a technical case study or regulatory scenario exercise, then close with a conversation involving the chief scientific officer or a board-level stakeholder before extending an offer.
Where can I find and apply to director of global regulatory affairs jobs?
You can find and apply to director of global regulatory affairs jobs on Migrate Mate, which lists current openings from across the United States. Search the listings to find roles that match your background and apply directly to each one that fits.
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