Head of Regulatory Affairs Jobs
Head of Regulatory Affairs jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer products, covering specializations in drug approval, compliance strategy, and labeling, from senior manager to VP and C-suite. See the openings below and apply to the ones that match your experience.
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Open roles10
Top stateMassachusetts
Top employerRevolution Medicines
Top cityCambridge, MA
Work type50% Remote
Top industryBiotechnology
Showing 5 of 10+ Head of Regulatory Affairs jobs
Global Head of Regulatory Affairs, Surgical Workflows
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Added 1w ago
Getinge
Global Head of Regulatory Affairs, Surgical Workflows
Wayne, New Jersey
Added 1w ago
Sr. Dir. Regulatory Affairs, Head of Global Labeling and Labeling Operations
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Added 1w ago
argenx
Sr. Dir. Regulatory Affairs, Head of Global Labeling and Labeling Operations
Remote
Added 1w ago
Vice President, Global Head of Regulatory Affairs
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Added 3w ago
QIAGEN
Vice President, Global Head of Regulatory Affairs
Germantown, Maryland
Added 3w ago
Head of Regulatory Affairs
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Added 1mo ago
PULPDENT Corporation
Head of Regulatory Affairs
Watertown, Massachusetts
Added 1mo ago
VP, Legal and Head of Regulatory Affairs - Patriot Hydro
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Added 1mo ago
LS Power Development, LLC
VP, Legal and Head of Regulatory Affairs - Patriot Hydro
Manchester, New Hampshire
Added 1mo ago
Added 1w ago
Global Head of Regulatory Affairs, Surgical Workflows
Getinge·Wayne, New Jersey
Job functions:
$240k - $280k/yr
Remote (US)
Bachelor's degree in engineering
10,000+ employees
Job Description
Global Head of Regulatory Affairs, Surgical Workflows
Date: Nov 4, 2026
Location:
Wayne, NJ, US
Company: Healthmark Industries Co., Inc.
Remote Work: 5 days at home (fully remote)
Salary Range: US $240,000 - $280,000 + 35% + Fleet Eligible
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
This position is open to candidates in US (east coast timezone preferred) and EUR- compensation based upon location.
Job Overview
The Global Head of Regulatory Affairs, Surgical Workflows, provides strategic and operational leadership for the Regulatory Affairs function across the business area.
The role is accountable for establishing and executing the global regulatory strategy, securing and maintaining market access, leading regulatory remediation, overseeing regulatory submissions and registrations, and managing critical interactions with regulatory authorities and Notified Bodies.
The position leads the Regulatory Affairs teams across Surgical Workflows and provides clear, risk-based recommendations to senior management. This includes an active role in product-safety and regulatory decision-making, including decisions related to Field Safety Corrective Actions, regulatory reporting and communication with authorities. The Global Head of Regulatory Affairs is responsible for the Regulatory Affairs organizations supporting all manufacturing sites and legal manufacturers within Surgical Workflows. The role has direct and indirect responsibility for the leadership, performance, development and effective coordination of Regulatory Affairs personnel across the business area.
Job Responsibilities and Essential Duties
Regulatory Leadership and Strategy
- Provide strategic leadership and direction for the Surgical Workflows Regulatory Affairs function.
- Define and implement regulatory objectives aligned with the Surgical Workflows strategy, portfolio and business priorities.
- Establish a clear global regulatory strategy covering new products, existing products, portfolio changes and market access.
- Monitor the global regulatory environment and translate emerging requirements into clear business actions and priorities.
- Keep the VP QRC, Surgical Workflows Management Team and relevant executive stakeholders informed about regulatory status, risks and critical decisions.
- Provide clear, risk-based recommendations on matters requiring executive attention, investment or prioritization.
Leadership of the Regulatory Affairs Organization
- Lead and manage the Regulatory Affairs teams across Surgical Workflows, including direct and indirect leadership responsibility.
- Define and develop an effective global RA operating model, with clear accountabilities, governance and interfaces between central, site and in-country RA teams.
- Set expectations, objectives and performance priorities for the RA organization.
- Ensure appropriate RA capacity and capabilities across the business area.
- Identify critical roles and capability gaps and establish robust development, talent and succession plans.
- Build a strong Regulatory Affairs community across the Surgical Workflows legal manufacturers and sites.
- Provide regulatory leadership, coaching and training to RA personnel and relevant cross-functional teams.
Regulatory Submissions and Market Access
- Develop and implement regulatory strategies for new product approvals, registrations and market introductions.
- Ensure the maintenance and renewal of licenses and registrations for the existing product portfolio.
- Oversee regulatory strategies and timelines for product-development and lifecycle-management projects.
- Ensure regulatory pathways, requirements, risks and alternative approaches are assessed early in product-development projects.
- Drive timely escalation and resolution of issues that could affect product registration, market access or commercialization.
- Ensure effective coordination between site RA teams and in-country RA organizations to secure and maintain valid product registrations and certificates.
Regulatory Remediation
- Lead regulatory remediation activities across Surgical Workflows where products, technical documentation, registrations or processes do not fully meet applicable regulatory requirements.
- Establish clear remediation scope, priorities, governance, decision rights, milestones and escalation mechanisms.
- Ensure remediation plans are risk-based, adequately resourced and integrated with Quality, R&D, Operations, Product Management and commercial priorities.
- Oversee remediation of regulatory documentation, product classifications, registrations, labeling, claims and market-access gaps.
- Ensure transparent reporting of remediation progress, risks, dependencies and decisions to senior management.
- Confirm that remediation outcomes are sustainable and appropriately embedded in the Regulatory Affairs organization and quality management system.
Product Safety and FSCA Decision-Making
- Provide senior Regulatory Affairs leadership in the assessment of potential product-safety and regulatory-compliance issues.
- Participate in and, where applicable, lead regulatory decision-making concerning reportability, field actions and Field Safety Corrective Actions.
- Ensure FSCA decisions are timely, risk-based, well documented and aligned with applicable regulatory requirements.
- Provide clear recommendations on regulatory reporting, authority notification, customer communication and market actions.
- Ensure appropriate alignment between Regulatory Affairs, Quality, Medical, Product Management, Legal, Operations and commercial stakeholders.
- Oversee regulatory interactions and commitments connected to FSCAs, recalls, safety notices and other corrective actions.
- Escalate significant patient-safety, compliance and business risks to the appropriate senior-management governance bodies.
Authority and Notified Body Relationship Management
- Develop and manage effective relationships and interfaces with regulatory authorities and Notified Bodies in key markets, including the United States, Europe, China, India and Australia.
- Lead or support critical meetings, submissions, responses and negotiations with regulatory authorities and Notified Bodies.
- Represent Getinge and Surgical Workflows in interactions with authorities, government entities and relevant industry associations.
- Ensure regulatory commitments made to authorities and Notified Bodies are clearly documented, assigned and completed.
- Establish appropriate strategies and communication cadences for significant compliance, remediation and market-access matters.
Compliance Support
- Collaborate with R&D, Operations, Product Portfolio Management, Quality, Medical, Legal, commercial teams and Corporate Quality and Regulatory functions to address regulatory and compliance challenges.
- Develop effective regulatory strategies and solutions that protect patient safety, maintain compliance and support business continuity.
- Support the development and implementation of effective regulatory processes, standards, governance and tools.
- Oversee execution and adjust priorities or approaches where necessary to achieve sustainable compliance.
- Promote effective cross-functional decision-making and communication across the business area.
Regulatory Intelligence
- Represent Surgical Workflows Regulatory Affairs within the corporate Quality and Regulatory organization.
- Collaborate with Corporate Regulatory Affairs on regulatory intelligence and emerging requirements.
- Lead the assessment and implementation of relevant regulatory-intelligence actions across Surgical Workflows.
- Provide independent subject-matter expertise while balancing regulatory requirements, patient safety and business considerations.
- Advise product teams on regulatory requirements related to product development, portfolio changes and acquisition integration.
In-Country Regulatory Compliance
- Ensure continued license to operate in all relevant markets.
- Develop robust registration and re-registration strategies for the Surgical Workflows product portfolio.
- Establish an effective framework for collaboration between site RA teams and in-country RA organizations.
- Ensure the timely availability and quality of regulatory documentation required for registrations, renewals and authority submissions.
- Maintain oversight of critical certificates, registrations, commitments and market-access risks.
Minimum Requirements
- Minimum 15 years of direct Regulatory Affairs experience.
- Bachelor’s degree in science, engineering, technology or another relevant discipline, or equivalent relevant experience.
- Minimum 10 years of direct management experience leading global Regulatory Affairs teams.
- Significant experience within the medical-device industry or another highly regulated healthcare environment.
- Demonstrated experience with global product registrations, regulatory authority interactions and lifecycle management.
- Experience leading significant regulatory remediation and complex compliance matters.
- Experience supporting or making decisions concerning regulatory reporting, field actions and FSCAs.
- Authority
- Authorized to lead Regulatory Affairs personnel across the Surgical Workflows Quality & Regulatory Compliance organization and relevant Getinge entities.
- Authorized to establish regulatory priorities, governance and escalation requirements across the business area.
- Accountable for providing independent regulatory recommendations on market access, compliance, remediation, product safety and FSCAs.
- Financial and employment-related authorities apply within the formally defined authorization framework.
Required Knowledge, Skills, and Abilities
- Extensive expertise in medical-device regulatory pathways, including FDA 510(k), PMA, EU MDR and international product registrations.
- Demonstrated experience in leading complex regulatory remediation programs.
- Strong knowledge of post-market regulatory requirements, regulatory reporting, recalls and FSCAs.
- Experience in direct interactions with global regulatory authorities and Notified Bodies.
- Proven ability to develop and execute regulatory strategies across a global organization.
- Strong leadership experience managing geographically dispersed Regulatory Affairs teams.
- Ability to make and communicate clear, risk-based decisions on complex product-safety and regulatory matters.
- Ability to operate effectively in a complex, matrixed organization and influence senior cross-functional stakeholders.
- Strong executive communication, stakeholder-management and escalation skills.
- Ability to translate regulatory requirements into clear, actionable and motivating objectives.
Supervision/Management of Others
- Direct and indirect responsibility for the management and development of Regulatory Affairs personnel supporting the Surgical Workflows businesses.
- Responsible for defining and developing a robust RA organization aligned with the Surgical Workflows strategic roadmap.
- Responsible for identifying critical positions, strengthening leadership capabilities and establishing talent-development and succession plans.
Internal and External Contacts/Relationships
- Internal stakeholders include:
- Surgical Workflows Regulatory Affairs and Quality teams
- Surgical Workflows Management Team
- R&D, Operations and Product Portfolio Management
- Medical, Legal and commercial functions
- In-country Regulatory Affairs teams
- Corporate Quality and Regulatory functions
- Getinge Executive Committee stakeholders, as applicable
- External stakeholders include:
- Global health and regulatory authorities
- European Notified Bodies
- U.S. Food and Drug Administration
- Other government and regulatory entities
- Relevant industry and trade associations
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions
- May work extended hours during peak business cycles
- The role requires international travel. Travel anticipated to average 25% annually but may vary depending on business needs
Special Requirements
- Global responsibility across Surgical Workflows businesses, legal manufacturers, locations and sites.
- Domestic and international travel is required.
- The position may be remote or hybrid, depending on business requirements.
- Extended working hours may occasionally be required during critical regulatory matters, authority interactions, remediation activities or field actions.
#LI-AS1
#LI-Remote
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Getinge
Global Head of Regulatory Affairs, Surgical Workflows
Wayne, New Jersey
Added 1w ago10,000+ employees
Job functions:
$240k - $280k/yr
Remote (US)
Bachelor's degree in engineering
Job Description
Global Head of Regulatory Affairs, Surgical Workflows
Date: Nov 4, 2026
Location:
Wayne, NJ, US
Company: Healthmark Industries Co., Inc.
Remote Work: 5 days at home (fully remote)
Salary Range: US $240,000 - $280,000 + 35% + Fleet Eligible
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
This position is open to candidates in US (east coast timezone preferred) and EUR- compensation based upon location.
Job Overview
The Global Head of Regulatory Affairs, Surgical Workflows, provides strategic and operational leadership for the Regulatory Affairs function across the business area.
The role is accountable for establishing and executing the global regulatory strategy, securing and maintaining market access, leading regulatory remediation, overseeing regulatory submissions and registrations, and managing critical interactions with regulatory authorities and Notified Bodies.
The position leads the Regulatory Affairs teams across Surgical Workflows and provides clear, risk-based recommendations to senior management. This includes an active role in product-safety and regulatory decision-making, including decisions related to Field Safety Corrective Actions, regulatory reporting and communication with authorities. The Global Head of Regulatory Affairs is responsible for the Regulatory Affairs organizations supporting all manufacturing sites and legal manufacturers within Surgical Workflows. The role has direct and indirect responsibility for the leadership, performance, development and effective coordination of Regulatory Affairs personnel across the business area.
Job Responsibilities and Essential Duties
Regulatory Leadership and Strategy
- Provide strategic leadership and direction for the Surgical Workflows Regulatory Affairs function.
- Define and implement regulatory objectives aligned with the Surgical Workflows strategy, portfolio and business priorities.
- Establish a clear global regulatory strategy covering new products, existing products, portfolio changes and market access.
- Monitor the global regulatory environment and translate emerging requirements into clear business actions and priorities.
- Keep the VP QRC, Surgical Workflows Management Team and relevant executive stakeholders informed about regulatory status, risks and critical decisions.
- Provide clear, risk-based recommendations on matters requiring executive attention, investment or prioritization.
Leadership of the Regulatory Affairs Organization
- Lead and manage the Regulatory Affairs teams across Surgical Workflows, including direct and indirect leadership responsibility.
- Define and develop an effective global RA operating model, with clear accountabilities, governance and interfaces between central, site and in-country RA teams.
- Set expectations, objectives and performance priorities for the RA organization.
- Ensure appropriate RA capacity and capabilities across the business area.
- Identify critical roles and capability gaps and establish robust development, talent and succession plans.
- Build a strong Regulatory Affairs community across the Surgical Workflows legal manufacturers and sites.
- Provide regulatory leadership, coaching and training to RA personnel and relevant cross-functional teams.
Regulatory Submissions and Market Access
- Develop and implement regulatory strategies for new product approvals, registrations and market introductions.
- Ensure the maintenance and renewal of licenses and registrations for the existing product portfolio.
- Oversee regulatory strategies and timelines for product-development and lifecycle-management projects.
- Ensure regulatory pathways, requirements, risks and alternative approaches are assessed early in product-development projects.
- Drive timely escalation and resolution of issues that could affect product registration, market access or commercialization.
- Ensure effective coordination between site RA teams and in-country RA organizations to secure and maintain valid product registrations and certificates.
Regulatory Remediation
- Lead regulatory remediation activities across Surgical Workflows where products, technical documentation, registrations or processes do not fully meet applicable regulatory requirements.
- Establish clear remediation scope, priorities, governance, decision rights, milestones and escalation mechanisms.
- Ensure remediation plans are risk-based, adequately resourced and integrated with Quality, R&D, Operations, Product Management and commercial priorities.
- Oversee remediation of regulatory documentation, product classifications, registrations, labeling, claims and market-access gaps.
- Ensure transparent reporting of remediation progress, risks, dependencies and decisions to senior management.
- Confirm that remediation outcomes are sustainable and appropriately embedded in the Regulatory Affairs organization and quality management system.
Product Safety and FSCA Decision-Making
- Provide senior Regulatory Affairs leadership in the assessment of potential product-safety and regulatory-compliance issues.
- Participate in and, where applicable, lead regulatory decision-making concerning reportability, field actions and Field Safety Corrective Actions.
- Ensure FSCA decisions are timely, risk-based, well documented and aligned with applicable regulatory requirements.
- Provide clear recommendations on regulatory reporting, authority notification, customer communication and market actions.
- Ensure appropriate alignment between Regulatory Affairs, Quality, Medical, Product Management, Legal, Operations and commercial stakeholders.
- Oversee regulatory interactions and commitments connected to FSCAs, recalls, safety notices and other corrective actions.
- Escalate significant patient-safety, compliance and business risks to the appropriate senior-management governance bodies.
Authority and Notified Body Relationship Management
- Develop and manage effective relationships and interfaces with regulatory authorities and Notified Bodies in key markets, including the United States, Europe, China, India and Australia.
- Lead or support critical meetings, submissions, responses and negotiations with regulatory authorities and Notified Bodies.
- Represent Getinge and Surgical Workflows in interactions with authorities, government entities and relevant industry associations.
- Ensure regulatory commitments made to authorities and Notified Bodies are clearly documented, assigned and completed.
- Establish appropriate strategies and communication cadences for significant compliance, remediation and market-access matters.
Compliance Support
- Collaborate with R&D, Operations, Product Portfolio Management, Quality, Medical, Legal, commercial teams and Corporate Quality and Regulatory functions to address regulatory and compliance challenges.
- Develop effective regulatory strategies and solutions that protect patient safety, maintain compliance and support business continuity.
- Support the development and implementation of effective regulatory processes, standards, governance and tools.
- Oversee execution and adjust priorities or approaches where necessary to achieve sustainable compliance.
- Promote effective cross-functional decision-making and communication across the business area.
Regulatory Intelligence
- Represent Surgical Workflows Regulatory Affairs within the corporate Quality and Regulatory organization.
- Collaborate with Corporate Regulatory Affairs on regulatory intelligence and emerging requirements.
- Lead the assessment and implementation of relevant regulatory-intelligence actions across Surgical Workflows.
- Provide independent subject-matter expertise while balancing regulatory requirements, patient safety and business considerations.
- Advise product teams on regulatory requirements related to product development, portfolio changes and acquisition integration.
In-Country Regulatory Compliance
- Ensure continued license to operate in all relevant markets.
- Develop robust registration and re-registration strategies for the Surgical Workflows product portfolio.
- Establish an effective framework for collaboration between site RA teams and in-country RA organizations.
- Ensure the timely availability and quality of regulatory documentation required for registrations, renewals and authority submissions.
- Maintain oversight of critical certificates, registrations, commitments and market-access risks.
Minimum Requirements
- Minimum 15 years of direct Regulatory Affairs experience.
- Bachelor’s degree in science, engineering, technology or another relevant discipline, or equivalent relevant experience.
- Minimum 10 years of direct management experience leading global Regulatory Affairs teams.
- Significant experience within the medical-device industry or another highly regulated healthcare environment.
- Demonstrated experience with global product registrations, regulatory authority interactions and lifecycle management.
- Experience leading significant regulatory remediation and complex compliance matters.
- Experience supporting or making decisions concerning regulatory reporting, field actions and FSCAs.
- Authority
- Authorized to lead Regulatory Affairs personnel across the Surgical Workflows Quality & Regulatory Compliance organization and relevant Getinge entities.
- Authorized to establish regulatory priorities, governance and escalation requirements across the business area.
- Accountable for providing independent regulatory recommendations on market access, compliance, remediation, product safety and FSCAs.
- Financial and employment-related authorities apply within the formally defined authorization framework.
Required Knowledge, Skills, and Abilities
- Extensive expertise in medical-device regulatory pathways, including FDA 510(k), PMA, EU MDR and international product registrations.
- Demonstrated experience in leading complex regulatory remediation programs.
- Strong knowledge of post-market regulatory requirements, regulatory reporting, recalls and FSCAs.
- Experience in direct interactions with global regulatory authorities and Notified Bodies.
- Proven ability to develop and execute regulatory strategies across a global organization.
- Strong leadership experience managing geographically dispersed Regulatory Affairs teams.
- Ability to make and communicate clear, risk-based decisions on complex product-safety and regulatory matters.
- Ability to operate effectively in a complex, matrixed organization and influence senior cross-functional stakeholders.
- Strong executive communication, stakeholder-management and escalation skills.
- Ability to translate regulatory requirements into clear, actionable and motivating objectives.
Supervision/Management of Others
- Direct and indirect responsibility for the management and development of Regulatory Affairs personnel supporting the Surgical Workflows businesses.
- Responsible for defining and developing a robust RA organization aligned with the Surgical Workflows strategic roadmap.
- Responsible for identifying critical positions, strengthening leadership capabilities and establishing talent-development and succession plans.
Internal and External Contacts/Relationships
- Internal stakeholders include:
- Surgical Workflows Regulatory Affairs and Quality teams
- Surgical Workflows Management Team
- R&D, Operations and Product Portfolio Management
- Medical, Legal and commercial functions
- In-country Regulatory Affairs teams
- Corporate Quality and Regulatory functions
- Getinge Executive Committee stakeholders, as applicable
- External stakeholders include:
- Global health and regulatory authorities
- European Notified Bodies
- U.S. Food and Drug Administration
- Other government and regulatory entities
- Relevant industry and trade associations
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions
- May work extended hours during peak business cycles
- The role requires international travel. Travel anticipated to average 25% annually but may vary depending on business needs
Special Requirements
- Global responsibility across Surgical Workflows businesses, legal manufacturers, locations and sites.
- Domestic and international travel is required.
- The position may be remote or hybrid, depending on business requirements.
- Extended working hours may occasionally be required during critical regulatory matters, authority interactions, remediation activities or field actions.
#LI-AS1
#LI-Remote
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
See All 10 Head of Regulatory Affairs Jobs
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Find JobsHead of Regulatory Affairs Job Market
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
What Employers Look For
The qualifications that appear most often in head of regulatory affairs jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or engineering
- 10 or more years of regulatory affairs experience across pharmaceutical or medical device sectors
- Proven experience leading FDA submissions including IND, NDA, BLA, 510(k), or PMA filings
- Deep knowledge of 21 CFR regulations, ICH guidelines, and GxP compliance frameworks
- RAC certification from the Regulatory Affairs Professionals Society preferred or required
- Experience managing cross-functional teams and presenting regulatory strategy to executive leadership
Tips for Your Head of Regulatory Affairs Job Search
Tailor your resume to submission type
Hiring managers want to see the specific regulatory pathways you've owned, NDA, BLA, 510(k), PMA, or EU MDR. List the exact submission types and agencies you've worked with, not just the product categories.
Apply early to roles that fit
Migrate Mate lists head of regulatory affairs openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Highlight your agency relationship experience
Many postings screen for direct FDA, EMA, or Health Canada interaction. Your resume should name the divisions you've engaged, the meeting types you've led, and the outcomes, not just that you have regulatory experience.
Filter openings by development stage
Early-stage companies need heads of regulatory affairs who can build frameworks from scratch, while commercial-stage companies prioritize post-market surveillance and label maintenance. Matching your background to the company's pipeline stage sharpens your application.
Prepare a submission timeline story for interviews
Interviewers for head of regulatory affairs roles consistently ask how you've managed competing approval timelines. Prepare a specific example with the product, the regulatory pathway, the obstacle, and the outcome you delivered.
Negotiate scope alongside title and compensation
At the head level, the reporting structure and team size matter as much as pay. During offer discussions, clarify whether the role owns global strategy, which geographies are in scope, and whether you'll build or inherit a team.
Head of Regulatory Affairs Jobs: Frequently Asked Questions
Which companies are hiring the most head of regulatory affairss?
The most active employers for head of regulatory affairss right now are Revolution Medicines, Roche, and ARTBIO, and the most openings are in Massachusetts, California, and New Jersey, based on current listings on Migrate Mate as of November 2026. Activity shifts with product pipeline milestones, so checking current listings gives you the most accurate picture.
How many head of regulatory affairs jobs are remote?
About 67% of head of regulatory affairs openings are fully remote or hybrid as of November 2026, reflecting broader flexibility at the director and VP level. Regulatory strategy, policy writing, and agency correspondence roles tend to be the most remote-friendly, while positions requiring on-site lab access or manufacturing oversight are more likely to require in-person presence.
How do you become a head of regulatory affairs?
Most heads of regulatory affairs start with a degree in a life science, pharmacy, or engineering field and spend several years in hands-on submission work before moving into team leadership. Building depth in a specific pathway, such as small molecule drugs or combination products, then broadening your agency experience across FDA divisions positions you for director-level roles. Earning a RAC credential demonstrates strategic knowledge beyond submission mechanics and signals readiness for senior leadership.
Can you get hired as a head of regulatory affairs without direct senior experience?
Candidates stepping up from a director or senior manager role can be competitive if they've already owned end-to-end submissions, managed external consultants, and presented regulatory strategy to leadership. Demonstrating that you've functioned at the head level in practice, even without the title, is what most hiring managers weigh. Targeting earlier-stage or smaller companies is a realistic entry point, since they often prioritize hands-on expertise over years of formal management.
What does the head of regulatory affairs interview process look like?
The process typically runs three to four rounds. An initial screen with HR or a talent partner focuses on background and culture fit. A second conversation with the hiring manager or CMO goes deep on specific submissions you've led and your approach to agency strategy. A final round often includes a panel with cross-functional peers from clinical, legal, or commercial, and sometimes a brief presentation on how you'd approach a regulatory challenge relevant to their pipeline.
Where can I find and apply to head of regulatory affairs jobs?
You can find and apply to head of regulatory affairs jobs on Migrate Mate, which lists current openings from across the United States. Search for roles that fit your background, whether you specialize in pharmaceuticals, medical devices, or biologics, and apply directly to each listing that matches your experience.
See All 10 Head of Regulatory Affairs Jobs
Find roles that match your experience and apply in just a few clicks.
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