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 #J-18808-Ljbffr EPM Scientific