CMC Regulatory Lead

Retro•Redwood City, CA

1d•Onsite

About The Position

Retro develops therapies for diseases driven by the biology of aging. We focus on cellular reprogramming and autophagy to rejuvenate cell and tissue function with the ultimate aim of adding 10 years to healthy human lifespan. We’re hiring an experienced CMC Regulatory Lead to 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 leader of Regulatory Affairs. This position is an onsite role based in Redwood City.

Requirements

Have a bachelor’s degree in a life sciences discipline or equivalent (advanced degree preferred).
7+ years of hands-on experience in regulatory CMC.
Demonstrated experience leading CMC regulatory strategy for cell therapies.
Experience working in early phase development (IND/CTA-enabling through Phase 1/2) with pragmatic, stage-appropriate CMC approaches.
Proven ability to lead cross-functional workstreams, manage multiple priorities, and deliver high-quality outputs under tight timelines.
Strong interest in longevity and aging biology, and motivation to work in a field where the playbook is still being written.

Nice To Haves

Have experience working on iPSC-derived cell therapies.
Have experience across multiple product modalities (e.g., cell/gene therapy, small molecules, biologics, etc.).
Experience in late phase development (e.g., Phase 3) and registrational/commercial settings.
Extensive global experience, including in non-traditional jurisdictions and emerging markets.

Responsibilities

Be accountable for the regulatory CMC activities for Retro’s programs, which include both cell therapies and small molecules.
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.
Identify regulatory CMC risks and develop creative and innovative mitigation strategies.
Partner closely with key internal functions, including Analytical Development, Process Development, Scientific Operations, and Quality.
Provide regulatory CMC guidance and oversight to external CDMOs and other vendors.
Help establish scalable regulatory CMC processes and approaches in a growing biotech organization.