Senior Director / VP Regulatory Affairs
Senior Director / VP, Regulatory Affairs - Clinical-Stage Biotech (Remote)
Remote (US) | Reports to Head of Regulatory Affairs / CMO
About the Opportunity
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.
How to Apply
If you're interested or know someone who might be a strong fit, reach out on LinkedIn or at sydney.hewitt@epmscientific.com. This is a confidential search - company details will be shared under NDA with shortlisted candidates.
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