# Lead, Regulatory Affairs CMC - Cell Therapy & Novel Therapeutics at Retro Biosciences

- Company: Retro Biosciences
- What the company does: Retro Biosciences develops therapies that target aging biology to extend healthy human lifespan by 10 years.
- Company website: https://www.retro.bio
- Type: Startups
- Level: Senior
- Location: Redwood City, CA
- Work setup: On-site
- Pay: $225K to $260K base salary per year (USD)
- Posted: 2026-06-22
- Apply by: 2026-10-08
- Apply: https://jobs.lever.co/retro/2f9b3bc9-2f9e-43c0-8416-841a5e645e02
- Page: https://www.1752.vc/careers/jobs/retro-biosciences-lead-regulatory-affairs-cmc-cell-therapy-and-novel-therapeutic/

## About the role

We’re hiring an experienced new member of our Regulatory team who will own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work. As one of the earliest members of the Regulatory Affairs team, you will work across Retro’s programs and play a leading role in building out the regulatory CMC capabilities and strategies to achieve our ambitious mission and tackle aging. You will report directly to the Head of Regulatory Affairs.

## What they're looking for

- Be accountable for the regulatory CMC activities for Retro’s pipeline, which has an emphasis on cell therapies but also contains small molecules, gene therapies, and AI-designed proteins
- Develop the regulatory CMC strategy for each program and lead the execution of global CMC regulatory plans
- Lead the preparation of the CMC dossier for INDs/CTAs and marketing applications, as well as the CMC documents for amendments, annual reports, and other CMC regulatory submissions
- Act as Retro’s regulatory liaison with health authorities for CMC communications and submissions
- Lead health-authority meetings with FDA and other health authorities for CMC-related topics
- Lead the responses to health-authority queries and information requests related to CMC

Tags: Regulatory