Senior Director Regulatory Affairs
Senior Director, Regulatory Affairs - Clinical-Stage Biotech (Bay Area)
A well-funded, clinical-stage biotech in the San Francisco Bay Area is expanding its regulatory leadership team as it advances a pipeline of first-in-class programs toward pivotal readouts and major filings.
This is a high-impact role for a strategic regulatory leader who wants a true seat at the table - serving as the Regulatory Lead across assigned programs and a key advisor to executive leadership on strategy, risk, and health authority engagement.
What you'll do
- Own and drive global regulatory strategy across development, registration, and life-cycle management
- Lead major global marketing applications (BLA, NDA, and/or MAA) end to end
- Manage FDA, EMA, and global health authority interactions - briefing docs, meeting prep, and negotiation
- Lead planning for key milestones: INDs, CTAs, and expedited pathways (Fast Track, Breakthrough, PRIME, Orphan Drug)
- Partner cross-functionally with Clinical, CMC, Quality, and Medical Affairs
- Mentor and build out a growing regulatory team
What we're looking for
- PhD/PharmD with 12+ years in Regulatory Affairs, or BS/MS with 14+ years
- Proven track record leading major marketing application submissions (BLA/NDA/MAA)
- Direct FDA and EMA experience; deep CTD/eCTD knowledge
- Strong regulatory writing and the ability to influence senior leadership
- Biologics and/or small molecule development experience - ophthalmology preferred
The details
- Comp: $265K-$285K base
- Location: Bay Area - hybrid, with regular onsite collaboration (candidates should be within commuting distance or open to relocating)
If this sounds like your next move - or you know someone who'd be a great fit - reach out. Happy to share more in a confidential conversation!
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