Lead, Regulatory Affairs CMC - Cell Therapy & Novel Therapeutics

Job description

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 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. This position is an onsite role based in Redwood City. **About you:** 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. 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 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 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. ### In this role, you will: - 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. - 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. ### You will thrive in this role if you: - 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. ### It’s a bonus if you: - 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.