Head of Regulatory Strategy

EPM Scientific; San Francisco (CA); Hybrid; USD 300,000 - 400,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

EPM Scientific is seeking a Regulatory Affairs Director/VP in the San Francisco Bay Area. This senior role focuses on driving global regulatory strategy across development programs and involves direct interactions with senior leadership and health authorities.

The ideal candidate has 12+ years in regulatory affairs, advanced degrees like PharmD or PhD, and hands-on experience with NDA/BLA approvals. The position offers a hybrid work model and a competitive salary ranging from $300,000 to $400,000 plus benefits.

Qualifications

• 12+ years in regulatory affairs within pharma or biotech.
• Proven experience with NDA or BLA submissions.
• Hands-on regulatory leadership experience.

Responsibilities

• Lead global regulatory strategy from early development through post-approval.
• Prepare NDA/BLA submissions in eCTD format.
• Conduct face-to-face meetings with FDA, EMA, and other health authorities.

Skills

Global regulatory knowledge

Strong FDA interaction history

NDA/BLA approval experience

Education

Advanced degree - PharmD, PhD, or MD

Job description

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