Director / Senior Director Regulatory CMC - Gene Therapy

EPM Scientific; San Francisco (CA); On-site; USD 240,000 - 360,000; Full time

Job summary

EPM Scientific is partnering with a clinical-stage gene therapy biotech to build out its regulatory CMC function as programs move toward late-stage development. This is a high-visibility role to own CMC regulatory strategy and interact directly with the FDA.

You will lead regulatory strategy for AAV gene therapy programs from IND through BLA, author Module 3, engage with CBER/OTP, and help build scalable CMC processes across teams and CDMOs.

Qualifications

• 10+ years in biotech/pharma with 5+ years in Regulatory CMC.
• Hands-on cell and/or gene therapy experience; AAV preferred.
• Direct experience with CBER submissions and health authority meetings.

Responsibilities

• Lead CMC regulatory strategy for AAV/viral vector gene therapy programs from IND through BLA
• Author and review Module 3 content for INDs, amendments, and BLA submissions
• Serve as the CMC point of contact for FDA (CBER/OTP) interactions and meetings
• Partner with Process Development, Analytical, Quality, and external CDMOs on comparability, potency, and control strategies
• Help build scalable regulatory CMC processes as the company grows

Skills

Regulatory CMC strategy

FDA interactions

Gene therapy experience

AAV knowledge

IND/BLA submissions

Education

BS/MS/PhD in a scientific discipline

Job description

Director / Senior Director, Regulatory Affairs CMC - Gene Therapy

I'm partnering with a clinical-stage gene therapy biotech building out its regulatory CMC function as its programs move toward late-stage development. This is a high-visibility role for someone who wants to own CMC regulatory strategy and work directly with FDA.

What you’ll do:

• Lead CMC regulatory strategy for AAV/viral vector gene therapy programs from IND through BLA
• Author and review Module 3 content for INDs, amendments, and BLA submissions
• Serve as the CMC point of contact for FDA (CBER/OTP) interactions and meetings
• Partner with Process Development, Analytical, Quality, and external CDMOs on comparability, potency, and control strategies
• Help build scalable regulatory CMC processes as the company grows

What we’re looking for:

• BS/MS/PhD in a scientific discipline, with 10+ years in biotech/pharma and 5+ years in Regulatory CMC
• Hands‑on cell and/or gene therapy experience; AAV strongly preferred
• Direct experience with CBER submissions and health authority meetings
• Comfortable in a lean, hands‑on environment, both strategic and in the weeds
• Late‑stage or BLA experience is a plus