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 approvalServe as a primary point of contact with FDA (and other health authorities), leading Type B/C meetings, briefing documents, and agency negotiationsGuide registration pathways across a range of indications and modalitiesPartner cross-functionally with Clinical, CMC, Safety, and Quality to align regulatory strategy with development timelinesAdvise 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 ownershipDirect, hands-on experience with late-stage/registrational programs (Phase 3 through submission)Primary or lead FDA interaction experience - meetings, briefing books, agency correspondenceOpen to candidates across therapeutic backgrounds - oncology, immunology, neuroscience, rare disease, or other specialty areas all consideredComfortable 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.