Senior Level Regulatory Affairs Lead Jobs
Senior level regulatory affairs lead jobs place experienced professionals in charge of regulatory strategy, submission ownership, and the cross-functional teams that execute against agency timelines. Hiring concentrates in Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Medical Devices, with 31% of openings posted as remote or hybrid, 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 Lead 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 Lead Jobs: Frequently Asked Questions
How do I get a senior level regulatory affairs lead job?
Employers at this level look for candidates who have owned a regulatory submission from strategy through approval, not just contributed to one. Demonstrated experience leading cross-functional teams, managing agency interactions directly, and mentoring junior staff carries significant weight. A history of navigating complex or novel regulatory pathways, along with deep familiarity with the relevant agency's expectations, is what separates strong candidates from the rest.
Which companies hire senior level regulatory affairs leads?
Companies hiring senior level regulatory affairs leads 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 tends to come from established manufacturers, large contract research organizations, and growth-stage companies building out their regulatory functions ahead of major submissions or product launches.
Are there remote senior level regulatory affairs lead jobs?
Yes, though availability varies by employer and product type. About 31% of senior level regulatory affairs lead openings are remote or hybrid as of September 2026, reflecting the document-intensive and consultation-heavy nature of the work. Roles tied to lab-based programs or requiring frequent site visits are more likely to be on-site, while strategy and submission-focused positions offer more location flexibility.
What makes a regulatory affairs lead role senior level?
Senior level regulatory affairs lead roles are defined by ownership rather than execution. You set the regulatory strategy for a product or portfolio, make decisions about agency engagement, and are accountable for submission quality and timeline. These roles also carry a mentoring responsibility, with junior and mid-level staff looking to you for technical guidance and review. The scope is broader and the decisions carry more consequence than at mid level.
Which industries hire the most senior level regulatory affairs leads?
Senior level regulatory affairs lead 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 demand because they operate under the most rigorous agency oversight, where experienced regulatory leadership directly affects product approval timelines, compliance standing, and the company's ability to bring new products to market.