Senior Level Regulatory Affairs Director Jobs
Senior level regulatory affairs director jobs place experienced professionals in charge of regulatory strategy, cross-functional submission programs, and the teams that drive agency approvals. Openings concentrate across Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Medical Devices, with a mix of on-site, hybrid, and remote positions available, 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 Director 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 Director Jobs: Frequently Asked Questions
How do I get a senior level regulatory affairs director job?
Employers at this level expect candidates who have owned regulatory strategy end-to-end, not just executed tasks. Demonstrating a history of leading submissions, managing agency relationships directly, and mentoring junior staff gives your application the strongest signal. Highlight cross-functional leadership, therapeutic area depth, and any experience navigating complex agency interactions such as pre-submission meetings or advisory committee preparation.
Which companies hire senior level regulatory affairs directors?
Companies hiring senior level regulatory affairs directors 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 large pharmaceutical and medical device manufacturers, established biotech firms, and contract research organizations that manage regulatory programs across multiple therapeutic areas or product lines.
Are there remote senior level regulatory affairs director jobs?
Yes, though availability varies by employer and therapeutic area. About 31% of senior level regulatory affairs director openings are remote or hybrid as of September 2026, reflecting how much of this work centers on documentation, strategy, and agency correspondence rather than on-site lab or manufacturing presence. Some roles with significant cross-functional or site-facing responsibilities remain on-site.
What makes a regulatory affairs director role senior level?
Senior level regulatory affairs director roles are defined by strategic ownership rather than execution support. Responsibilities typically include setting regulatory strategy for a product portfolio, leading agency interactions independently, overseeing submission teams, and mentoring regulatory affairs professionals at earlier career stages. The expectation shifts from completing assigned work to setting direction, resolving complex regulatory questions, and representing the function in cross-functional leadership discussions.
Which industries hire the most senior level regulatory affairs directors?
Senior Level regulatory affairs director 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 strict premarket approval, post-market surveillance, and quality system requirements that demand experienced regulatory leadership to manage product lifecycles and agency relationships.