Director, Regulatory Affairs CMC

About the role

The Director, Regulatory Affairs CMC will own the end-to-end strategy and execution of Chemistry, Manufacturing, and Controls regulatory programs for Retro. This role defines and drives the global CMC regulatory framework that ensures our advanced therapeutic candidates are developed in accordance with regulatory expectations. The hire will act as the central architect of our CMC regulatory strategy, proactively identifying potential regulatory questions and shaping our development plans to mitigate risk. You will translate complex scientific and manufacturing data into compelling regulatory narratives that facilitate efficient interactions with health authorities worldwide. As a key leader within the Regulatory Affairs function, you will partner closely with cross-functional teams to align scientific, manufacturing, and quality decisions with regulatory strategy. The Director will serve as the primary CMC regulatory advocate and trusted advisor during high-stakes interactions with regulatory officials. This position is critical for establishing the robust regulatory foundation necessary to advance our cell therapy programs toward clinical development and approval. You will build and evolve the CMC regulatory playbook for the company, creating structures and processes that support our ambitious mission to add 10 years to healthy human lifespan.

Key facts

What you'll do

Define and execute the global CMC regulatory strategy for all Retro therapeutic programs, ensuring alignment with the overall drug development and commercialization objectives.

Establish and maintain regulatory CMC frameworks, standard operating procedures, and governance models to ensure consistent compliance and efficiency across the organization.

Lead the preparation and submission of CMC sections for regulatory filings, including Investigational New Drug (IND) applications and variations, ensuring completeness and regulatory acceptance.

Serve as the primary internal and external CMC regulatory point person, leading interactions with health authorities and translating their feedback into actionable plans.

Develop and implement comprehensive CMC characterization, control, and validation strategies for advanced therapy medicinal products, with a focus on cell therapy modalities.

Champion risk management by proactively identifying potential CMC regulatory issues and developing mitigation strategies before they escalate during clinical development.

Collaborate with manufacturing, quality, and clinical teams to ensure CMC strategies are feasible, scalable, and aligned with clinical trial timelines and patient needs.

Build and mentor the CMC regulatory knowledge within the organization, creating a strong foundation of regulatory expertise and best practices.

Liaise with clinical and nonclinical teams to ensure that CMC considerations are integrated into the early-stage development plans and protocols.

Drive continuous improvement of the CMC regulatory processes, leveraging lessons learned from regulatory interactions and industry best practices.

Partner with external consultants and regulatory experts as needed to support specific CMC challenges or strategic initiatives.

Contribute to the broader regulatory landscape analysis, monitoring evolving guidelines and their potential impact on Retro's drug development programs.

Ensure that CMC documentation is clear, consistent, and audit-ready to support both regulatory submissions and internal quality assurance reviews.

Champion the mission of cellular reprogramming and autophagy by ensuring that the CMC regulatory strategy supports the timely advancement of innovative therapies for aging-related diseases.

Requirements

Candidates must possess a PhD or PharmD degree with a strong focus on pharmaceutical sciences, chemistry, or a related field.

You must have a JD degree or equivalent practical regulatory experience in the pharmaceutical or biotechnology industry.

A minimum of 10 years of progressively responsible experience in pharmaceutical or biotechnology CMC regulatory affairs is required.

You must have direct experience leading CMC regulatory submissions for advanced therapeutic medicinal products, including cell and gene therapies.

Demonstrated expertise in interpreting and applying current Good Manufacturing Practice (cGMP) regulations and guidance is mandatory.

You must have a proven track record of successful interactions with major health authorities, such as the FDA and EMA, on CMC matters.

Extensive knowledge of international regulatory guidelines and requirements for drug substance and drug product development is essential.

You must be highly proficient in preparing CMC sections of regulatory documents, ensuring clarity, completeness, and scientific rigor.

Nice to have

Prior experience in the biotechnology or pharmaceutical industry focused on cell therapy or regenerative medicine is strongly preferred.

Experience developing regulatory strategies for products involving cellular reprogramming or novel manufacturing platforms is a significant advantage.

Familiarity with regulatory pathways for advanced therapy medicinal products (ATMPs) and orphan drug designations is preferred.

Experience building and managing a regulatory team or leading cross-functional regulatory projects is highly valued.

Practical notes

This is an onsite role based in Redwood City, California.

Full-time engagement with standard business hours is expected.

Candidates must be eligible to work in the United States without sponsorship for this position.