# Senior Director, Regulatory Affairs at Orca Bio

- Company: Orca Bio
- What the company does: Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
- Company website: https://orcabio.com/
- Type: Startups
- Level: Principal and up
- Location: Menlo Park, CA
- Work setup: Remote
- Pay: $250K to $300K base salary per year (USD)
- Posted: 2026-07-30
- Apply by: 2026-10-08
- Apply: https://jobs.lever.co/orcabiosystems/db466798-001a-4d5a-bd14-32982956e856
- Page: https://www.1752.vc/careers/jobs/orca-bio-senior-director-regulatory-affairs/

## About the role

Position Summary: The Senior Director of Regulatory Affairs is Orca Bio's functional Head of Regulatory Affairs, leading the Regulatory Affairs function and serving as the company's primary regulatory subject-matter expert and advisor. The incumbent will assist the C-Suite to develop and prepare for regulatory strategy which should be agreed by the executive leadership. Significant strategy decisions and major agency positions remain subject to executive leadership approval.

## What they're looking for

- Bachelor’s degree in life sciences or a related discipline required
- 10+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry, including deep U.S. regulatory experience and meaningful experience working with global health authorities such as the EMA
- Track record of participating in approval of a commercial-stage product strongly preferred, experience in hematology, oncology, cell therapy, or bone marrow transplant preferred
- Demonstrated success managing post-approval regulatory activities, including commercial-stage supplements, labeling changes, annual reports, and post-marketing commitments
- Working knowledge of drug development and commercialization requirements, including clinical trial requirements, CMC, manufacturing, quality, post-marketing surveillance, and promotional review
- Proven people leader with a track record of building, coaching, and developing high-performing teams

Tags: Regulatory Affairs