Job Details

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