Senior Level Regulatory Affairs Associate Jobs
Senior level regulatory affairs associate jobs put experienced professionals in charge of submission strategy, cross-functional project ownership, and the regulatory decisions that move products through approval. Openings concentrate in Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Medical Devices, with a mix of on-site, remote, and hybrid roles, and employers like Revolution Medicines, Revolution Medicines, and Insmed Incorporated hiring at this level now.
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Showing 5 of 84+ Senior Level Regulatory Affairs Associate jobs
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 Associate 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 Associate Jobs: Frequently Asked Questions
How do I get a senior level regulatory affairs associate job?
Employers at this level look for professionals who have owned regulatory submissions end-to-end, not just supported them. Deep familiarity with agency guidance, a history of leading cross-functional teams, and the ability to interpret evolving requirements independently all carry significant weight. Candidates who can point to specific approvals they drove and junior staff they mentored have a clear edge in a competitive field.
Which companies hire senior level regulatory affairs associates?
Companies hiring senior level regulatory affairs associates 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 covers large pharmaceutical and medical device manufacturers, biotech firms, and contract research organizations that need seasoned professionals capable of leading complex submissions independently.
Are there remote senior level regulatory affairs associate jobs?
Yes, though availability varies by employer and therapeutic area. About 31% of senior level regulatory affairs associate openings are remote or hybrid as of September 2026, reflecting the document-intensive nature of the work. Roles tied to lab operations or requiring frequent agency interaction tend to remain on-site, while submission-focused positions often offer more flexibility.
What makes a regulatory affairs associate role senior level?
Senior level regulatory affairs associate roles are defined by autonomous ownership rather than task execution. At this stage, you are expected to set submission strategy, resolve complex regulatory questions without escalation, represent the organization in agency interactions, and mentor junior colleagues. The scope extends beyond individual filings to include process improvement, risk assessment, and influencing product development timelines from the regulatory perspective.
Which industries hire the most senior level regulatory affairs associates?
Senior Level regulatory affairs associate 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 face the most rigorous and high-stakes approval pathways, requiring professionals with the depth to manage submissions, respond to agency feedback, and keep complex product portfolios in compliance.