Retro

Director, Regulatory Affairs CMC — Cell Therapy & Novel Therapeutics

Redwood City, CA · Director

Sponsorship not specified$225k-$260kDetected 29 days ago

FDA RegulatoryCRISPRCommunicationCollaborationRegulatory Affairs

About the role

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.
You will report directly to the leader of Regulatory Affairs.
This position is an onsite role based in Redwood City.

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.
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.
Retro develops therapies for diseases driven by the biology of aging.
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.
Proven ability to lead cross-functional workstreams, manage multiple priorities, and deliver high-quality outputs under tight timelines.
You have high-collaboration and low-ego tendencies, with the ability to align cross-functional technical teams and external partners around a shared regulatory CMC plan and clear deliverables.

You are a builder and doer who can set clear, global CMC regulatory strategies and roll up your sleeves to execute them at speed.
You are energized by complex CMC challenges, especially in cell therapy, and you anticipate questions before they become risks.

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.
Have a bachelor's degree in a life sciences discipline or equivalent (advanced degree preferred).

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.

You translate technical details into clear regulatory narratives that resonate with health authorities, and you are comfortable serving as the CMC regulatory point person in high-stakes health-authority interactions.
You bring strong operational discipline, enjoy creating structure when needed, and are mission-driven with genuine motivation to advance longevity and aging biology for the benefit of humanity.
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.

This listing is sourced directly from Retro's careers page and normalized into a canonical job model.