Senior Level Regulatory Affairs Jobs
Senior level regulatory affairs jobs place experienced professionals in charge of submission strategy, cross-functional alignment, and the teams and processes that bring products through agency review. Openings concentrate across Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Medical Devices, with 31% remote or hybrid availability, and employers like Revolution Medicines, Revolution Medicines, and Insmed Incorporated hiring at this level now.
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Location: This position can be located in Thousand Oaks, CA, San Francisco Bay Area, CA or Washington, D.C. area
Overview
Reporting to the Vice President of Regulatory, the Director of Regulatory Affairs will support regulatory strategy and lead regulatory execution for the company’s development programs, ensuring compliance with global health authority requirements (FDA, EMA, and other regulatory agencies). This role will be responsible for developing and implementing regulatory activities to support the clinical development plans including leading submissions, managing regulatory vendors, support of regulatory interactions, and providing regulatory guidance to cross-functional teams.
Responsibilities
Regulatory Strategy & Leadership
- Lead execution and implementation of regulatory strategies to support product development.
- Support regulatory interactions with global health authorities, including FDA, EMA, MHRA, and others.
- Provide regulatory input into clinical development plans, study designs, labeling strategies etc.
- Anticipate and mitigate regulatory risks; develop contingency plans as needed.
Submissions & Compliance
- Oversee the preparation, review, and submission of high-quality regulatory documents (INDs, CTAs, NDAs, briefing documents, etc.).
- Ensure timely regulatory submissions are complete and accurate.
- Maintain current knowledge of applicable regulatory requirements and ensure organizational compliance.
- Lead/support preparation and management of regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent ex-US interactions.
Cross-Functional Collaboration
- Partner with Clinical Development, CMC, Nonclinical, Quality, and leadership teams to integrate regulatory considerations.
- Provide regulatory guidance on study protocols, statistical analysis plans, and clinical trial conduct.
- Quality mindset regarding CMC submissions and inspections.
Requirements
- Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences
- Minimum of 8 years of Regulatory experience
- Direct experience leading/supporting FDA interactions
- Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical and manage process from clinical development through to commercialization planning
- US registration experience ideal
- Experience with small molecules and pain (or similar area) is preferred
- Experienced with IND submission and maintenance
- Knowledge of US procedures (fast to market procedures would be an advantage)
- Familiarity with EU CTA/MAA regulatory processes preferred
- Regulatory Project Management experience preferred
- Excellent written and verbal communication skills
- Must display strong analytical and problem-solving skills.
- Attention to detail is essential.
Location: This position can be located in Thousand Oaks, CA, San Francisco Bay Area, CA or Washington, D.C. area
Overview
Reporting to the Vice President of Regulatory, the Director of Regulatory Affairs will support regulatory strategy and lead regulatory execution for the company’s development programs, ensuring compliance with global health authority requirements (FDA, EMA, and other regulatory agencies). This role will be responsible for developing and implementing regulatory activities to support the clinical development plans including leading submissions, managing regulatory vendors, support of regulatory interactions, and providing regulatory guidance to cross-functional teams.
Responsibilities
Regulatory Strategy & Leadership
- Lead execution and implementation of regulatory strategies to support product development.
- Support regulatory interactions with global health authorities, including FDA, EMA, MHRA, and others.
- Provide regulatory input into clinical development plans, study designs, labeling strategies etc.
- Anticipate and mitigate regulatory risks; develop contingency plans as needed.
Submissions & Compliance
- Oversee the preparation, review, and submission of high-quality regulatory documents (INDs, CTAs, NDAs, briefing documents, etc.).
- Ensure timely regulatory submissions are complete and accurate.
- Maintain current knowledge of applicable regulatory requirements and ensure organizational compliance.
- Lead/support preparation and management of regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent ex-US interactions.
Cross-Functional Collaboration
- Partner with Clinical Development, CMC, Nonclinical, Quality, and leadership teams to integrate regulatory considerations.
- Provide regulatory guidance on study protocols, statistical analysis plans, and clinical trial conduct.
- Quality mindset regarding CMC submissions and inspections.
Requirements
- Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences
- Minimum of 8 years of Regulatory experience
- Direct experience leading/supporting FDA interactions
- Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical and manage process from clinical development through to commercialization planning
- US registration experience ideal
- Experience with small molecules and pain (or similar area) is preferred
- Experienced with IND submission and maintenance
- Knowledge of US procedures (fast to market procedures would be an advantage)
- Familiarity with EU CTA/MAA regulatory processes preferred
- Regulatory Project Management experience preferred
- Excellent written and verbal communication skills
- Must display strong analytical and problem-solving skills.
- Attention to detail is essential.
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Find JobsSenior Level Regulatory Affairs Job Market
Who's Hiring
- Revolution Medicines21
- Insmed Incorporated3
- Insmed2
- BeOne Medicines2
Top Industries Hiring
- Biotechnology & Pharmaceuticals53
- Healthcare & Medical Services7
- Medical Devices5
- Consulting & Professional Services4
- Science & Research3
Senior Level Regulatory Affairs Jobs: Frequently Asked Questions
How do I get a senior level regulatory affairs job?
Employers hiring at the senior level look for professionals who have owned regulatory submissions end-to-end, not just supported them. A strong candidate brings direct experience managing agency interactions, guiding strategy across development stages, and mentoring junior staff. Demonstrated success with complex filings, cross-functional leadership, and the ability to interpret evolving guidance independently are what separate senior candidates from mid-level ones.
Which companies hire senior level regulatory affairs professionals?
Companies hiring senior level regulatory affairs professionals right now include Revolution Medicines, Revolution Medicines, and Insmed Incorporated, based on current listings on Migrate Mate as of September 2026. Hiring at this level comes primarily from established life sciences companies, medical device manufacturers, and contract research organizations that maintain in-house regulatory functions and need experienced professionals to lead them.
Are there remote senior level regulatory affairs jobs?
Yes, though availability varies by employer and product area. About 31% of senior level regulatory affairs openings are remote or hybrid as of September 2026, reflecting how document-driven and cross-functional this work tends to be. Roles tied to lab operations or frequent agency visits are more likely to require on-site presence, while strategy and submission-focused positions often allow flexibility.
What makes a regulatory affairs role senior level?
Senior level regulatory affairs roles are defined by ownership and scope rather than task execution. Professionals at this stage set submission strategy, make independent regulatory judgments, manage relationships with agencies, and are accountable for outcomes across a product or portfolio. They also mentor junior and mid-level staff and are expected to guide cross-functional teams through complex or ambiguous regulatory situations without day-to-day supervision.
Which industries hire the most senior level regulatory affairs professionals?
Senior level regulatory affairs roles concentrate in Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Medical Devices, based on current listings on Migrate Mate as of September 2026. These sectors drive hiring at this level because they operate under dense regulatory frameworks, face ongoing submission and compliance obligations, and need experienced professionals who can navigate agency expectations and lead product programs through approval.