Head of Regulatory Strategy
Regulatory Affairs Director / VP - Specialty Pharma | Bay Area (Hybrid)
A specialty pharmaceutical company based in the San Francisco Bay Area is looking for a senior regulatory leader to own and drive global regulatory strategy across their development programs.
This is a high-impact, hands-on role - you'll be working directly with senior leadership and health authorities, not just managing from a distance. If you're a scientist at heart who found their way into regulatory and loves the intersection of both, this one's worth a look.
What you'll be doing:
- Leading global regulatory strategy from early development through post-approval
- Owning and preparing NDA/BLA submissions in eCTD format
- Leading face-to-face meetings with FDA, EMA, and other health authorities
- Developing regulatory risk assessments and mitigation strategies
- Supporting market access and maintaining regulatory documentation across programs
What we're looking for:
- Advanced degree - PharmD, PhD, or MD
- 12+ years in regulatory affairs within pharma or biotech
- NDA or BLA approval experience (hands-on, not just oversight)
- Strong FDA interaction history
- Global regulatory knowledge
Location: San Francisco Bay Area - hybrid, 3 days in office. Must be local or already planning to relocate independently.
Level: Director to VP depending on experience
Salary: $300,000 - $400,000 base salary + benefits + bonus + equity