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Job description
We are partnering with a clinical-stage biotechnology company to appoint a Senior Director, Regulatory Affairs who will take a leading role in shaping and executing global regulatory strategy across a growing clinical pipeline.
This is a highly visible opportunity for an experienced regulatory leader who wants genuine program ownership, direct FDA interaction, and the ability to influence development strategy within a lean, fast-moving and science-driven biotech environment.
The Opportunity
As Senior Director, Regulatory Affairs, you will own regulatory strategy for one or more clinical-stage programs, supporting development from IND/CTA through late-stage development and preparation for potential marketing applications.
You will serve as a primary interface with the FDA and partner closely across Clinical Development, Clinical Operations, CMC, Nonclinical and Quality.
Importantly, this is not simply a submissions-focused position. You will have a meaningful voice in development strategy, protocol design, endpoint selection, evidence generation and regulatory pathway planning.
Key Responsibilities
Develop and execute global regulatory strategies for assigned clinical-stage programs.
Lead FDA interactions and formal agency meetings, including pre-IND, End-of-Phase 2, Type B/C and pre-NDA/BLA meetings.
Provide strategic regulatory input into integrated development plans, clinical protocols and evidence-generation strategies.
Identify and pursue opportunities for expedited regulatory pathways and designations.
Lead regulatory planning and oversight across INDs, CTAs, amendments, DSURs and designation requests, while driving future NDA/BLA/MAA readiness.
Coordinate regulatory interactions with international health authorities.
Represent Regulatory Affairs on cross-functional program teams and communicate regulatory strategy, risks and recommendations to executive leadership.
Help build regulatory infrastructure and capabilities as the organization and pipeline grow.
What We're Looking For
We're looking for an established regulatory professional with significant experience guiding clinical development programs and working directly with the FDA.
You will ideally bring 12+ years of biopharmaceutical industry experience, including 8+ years within Regulatory Affairs, with demonstrated success leading FDA interactions and formal agency meetings.
Strong experience developing global regulatory strategies, working across IND through NDA/BLA stages, and influencing cross-functional development teams will be important.
Experience within a clinical-stage or emerging biotech is particularly attractive, as is experience with expedited regulatory pathways and direct involvement in an NDA, BLA or MAA submission.
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.