CMC Regulatory Lead

About the 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 CMC Regulatory Lead to own the strategy and operations for our Chemistry, Manufacturing, and Controls (CMC) regulatory work.

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.

Requirements

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.

Qualifications

• 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.

Skills

Strong interest in longevity and aging biology, and motivation to work in a field where the playbook is still being written. Strong interest in longevity and aging biology, and motivation to work in a field where the playbook is still being written.

Benefits

We offer a total compensation package including medical, dental, and vision insurance for you and your family, a 401(k) plan with 4% matching, unlimited time off and 10 company holidays per year, paid parental leave, an annual learning & development stipend, a monthly longevity stipend, free lunch and snacks, and a supportive environment that fosters collaboration, open communication, and authenticity.

Pay

$200,000 - $240,000 a year

Schedule

This position is an onsite role based in Redwood City.