Retro Biosciences develops therapies that target aging biology to extend healthy human lifespan by 10 years.
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
More about this role
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.
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...
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