Mantell Associates
Mantell Associates is partnered with a pioneering precision genetic medicine company, who is seeking an experienced and strategic Director of Regulatory CMC to join its leadership team.
This senior role will drive regulatory strategy and execution for Chemistry, Manufacturing, and Controls (CMC) across clinical and commercial programs, ensuring safe, compliant, and efficient delivery of gene therapies to patients.
Director, Regulatory CMC – Responsibilities:
- Define and execute the global regulatory CMC strategy for assigned genetic therapy programs, from early development through commercialization
- Lead preparation, review, and submission of CMC regulatory filings (INDs, BLAs, CTAs, post-approval changes, supplements/variations) with FDA and other global health authorities
- Collaborate closely with Process Development, Manufacturing, Quality Assurance, and Analytical teams to ensure that CMC data, documentation, and manufacturing processes meet regulatory expectations and are aligned with clinical development plans
- Evaluate and manage regulatory risk associated with manufacturing changes, comparability studies, facility/technology transfers, stability, potency assays, and raw materials for genetic medicines
- Monitor and interpret evolving regulatory guidance for genetic therapies, gene editing, viral vectors, oligonucleotides, etc., and provide senior-leadership input on impact and strategy
- Lead cross-functional CMC regulatory teams, including mentoring, resource allocation, and ensuring documentation quality and regulatory compliance
Director, Regulatory CMC – Requirements:
- 10 years’ experience in regulatory affairs with substantial CMC responsibility, ideally in gene therapy, genetic medicine, or advanced biologics
- Regulatory CMC experience in AAV gene therapy across US and EU
- Prior BLA filing experience and ability to build a team around BLA execution
- Proven track record of successful regulatory submissions (IND/BLA etc.) for gene therapy or related biologic products in the US; experience with global/regional submissions is an advantage
- Deep understanding of FDA regulations, ICH guidelines, and regulatory expectations for CMC of genetic medicines—including vector manufacturing, potency assays, comparability, raw/ancillary materials, process controls, etc.
- Strong leadership, communication, and collaboration skills; experience leading cross-functional teams and influencing global stakeholders
- Ability to navigate complex regulatory challenges, anticipate issues, and develop strategies to mitigate risks while accelerating timelines
- Based in California, eligible to work in the US, with willingness to spend several days onsite per week
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at 44 (0)20 3854 7700.