Head of Regulatory Affairs

Head of Regulatory Affairs (SD/ED/VP)

This is a senior regulatory role with a company built around a genuinely novel mechanism. They've already taken it from concept through approval, treating a rare disease where there were no prior treatment options. The pipeline is now expanding into additional indications.

It's a small, scientifically-driven team, not a large regulatory function with layers between strategy and execution. The person in this seat works directly with senior leadership and is hands-on. Not just overseeing submissions, but able to write, defend, and own them.

The role:

• Own global regulatory strategy across development and post-approval programs
• Lead direct engagement with FDA, EMA, and other health authorities
• Drive submissions for NDAs, BLAs, and Orphan Drug Designations
• Operate as the scientific and regulatory authority internally

Who fits:

Someone who came up through the science and stayed close to it, rather than moving into pure process management. If you've personally written or rewritten a label, secured an orphan drug designation, or sat across from FDA and walked out with a clear path forward, that's the kind of experience this role is looking for.

• Advanced degree; PharmD, PhD, or MD
• 12+ years in regulatory affairs within pharma or biotech
• Direct ownership of an NDA or BLA submission, not just oversight of a team that handled it
• Strong FDA interaction history; orphan drug experience a plus
• Comfortable building in a lean environment rather than inheriting existing infrastructure

Location: San Francisco Bay Area; hybrid, 3 days in office

Level: Senior Director to VP, depending on experience

Compensation: Up to $400K base + bonus + equity