Senior Director / VP Regulatory Affairs

A well-funded, clinical-stage biotechnology company with a broad, multi-asset pipeline is expanding its regulatory leadership team as several programs advance toward late-stage development and registration. This is a high-visibility role for a regulatory leader who wants ownership over strategy - not just execution - across a diverse portfolio spanning multiple therapeutic areas.

What You'll Do

• Own global regulatory strategy for late-stage assets, from pivotal trial design through NDA/BLA submission and approval
• Serve as a primary point of contact with FDA (and other health authorities), leading Type B/C meetings, briefing documents, and agency negotiations
• Guide registration pathways across a range of indications and modalities
• Partner cross-functionally with Clinical, CMC, Safety, and Quality to align regulatory strategy with development timelines
• Advise executive leadership on regulatory risk and pathway options as the portfolio matures

What We're Looking For

• 10+ years in Regulatory Affairs within biotech or pharma, including senior-level ownership
• Direct, hands-on experience with late-stage/registrational programs (Phase 3 through submission)
• Primary or lead FDA interaction experience - meetings, briefing books, agency correspondence
• Open to candidates across therapeutic backgrounds - oncology, immunology, neuroscience, rare disease, or other specialty areas all considered
• Comfortable working fully remote, with periodic travel for key meetings or team collaboration

Why It's Interesting

Broad portfolio means exposure to multiple disease areas rather than a single program - genuine strategic latitude, executive visibility, and a direct hand in shaping how the company approaches upcoming filings.