Senior Director / VP Regulatory Affairs

EPM Scientific; California; Remote; USD 180,000 - 240,000; Full time

Job summary

EPM Scientific is seeking a Senior Director / VP, Regulatory Affairs for a clinical-stage biotech, in a fully remote US role reporting to Head of Regulatory Affairs / CMO.

You will own global regulatory strategy for late-stage assets, interact with FDA, lead meetings, and guide NDA/BLA submissions, partnering with Clinical, CMC, Safety, and Quality. The role offers executive visibility across a broad portfolio, with flexibility to work remotely and travel for key meetings.

Qualifications

• 10+ years in Regulatory Affairs with senior ownership.
• Experience with late-stage/registrational programs (Phase 3 through submission).
• Primary or lead FDA interaction experience.
• Open to multiple therapeutic areas.
• Comfortable with fully remote work.

Responsibilities

• Own global regulatory strategy for late-stage assets and NDA/BLA submissions.
• Lead FDA interactions, meetings, briefing documents, and agency negotiations.
• Guide registration pathways across 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.

Skills

Regulatory leadership

Late-stage programs (Phase 3+)

FDA interactions

Broad therapeutic scope

Remote work

Job description

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.