Head of Regulatory Affairs

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 #J-18808-Ljbffr