Senior Director Regulatory Affairs

About the role

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.

Responsibilities

• 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

Requirements

• 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

Pay

$265K–$285K base

Location

Bay Area—hybrid, with regular onsite collaboration (candidates should be within commuting distance or open to relocating)