Senior Level Regulatory Affairs Analyst Jobs
Senior level regulatory affairs analyst jobs place experienced professionals in charge of regulatory strategy, submission ownership, and the cross-functional teams or workflows that deliver compliance outcomes. Openings are concentrated across Biotechnology & Pharmaceuticals, Healthcare & Medical Services, and Medical Devices, with a mix of on-site, remote, and hybrid roles available, 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 Analyst 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 Analyst 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 Analyst Jobs: Frequently Asked Questions
How do I get a senior level regulatory affairs analyst job?
Employers at this level want demonstrated ownership of regulatory submissions, such as NDAs, 510(k)s, or BLAs, not just support work. Candidates who stand out show they have led agency interactions, resolved complex compliance issues independently, and mentored junior analysts. A strong submission portfolio, deep familiarity with relevant guidance documents, and experience coordinating across legal, clinical, and manufacturing teams will carry more weight than credentials alone.
Which companies hire senior level regulatory affairs analysts?
Companies hiring senior level regulatory affairs analysts 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, medical device, and biotech companies, as well as contract research organizations and regulatory consulting firms that staff experienced professionals on complex client engagements.
Are there remote senior level regulatory affairs analyst jobs?
Yes, though availability varies by employer and therapeutic area. About 31% of senior level regulatory affairs analyst openings are remote or hybrid as of September 2026, reflecting the document-driven and cross-functional nature of this work. Roles tied to manufacturing sites or requiring frequent in-person agency meetings are more likely to require on-site presence, while submission-focused and consulting roles often offer greater flexibility.
What makes a regulatory affairs analyst role senior level?
Senior level roles are defined by independent ownership rather than task execution. A senior regulatory affairs analyst leads submission strategy, owns relationships with regulatory agencies, and is accountable for outcomes, not just deliverables. These roles typically involve scoping regulatory pathways for new products, resolving complex agency questions, and mentoring or directing junior analysts. The expectation is that you bring judgment, not just process knowledge.
Which industries hire the most senior level regulatory affairs analysts?
Senior Level regulatory affairs analyst 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 rigorous federal oversight, require ongoing submissions throughout a product's lifecycle, and need experienced analysts who can navigate evolving agency expectations without close supervision.