Associate Director of Regulatory Affairs, CMC
About the role
This senior regulatory role supports late-stage development, commercial launch, and lifecycle management for an innovative cell therapy pipeline. You will provide hands‑on CMC regulatory expertise across global submissions, health authority interactions, and post‑approval activities. The position offers substantial ownership of complex regulatory content, including BLA, MAA, IND, and IMPD submissions and Module 3/CTD documentation. You will work closely with Quality, Process Development, Manufacturing, Analytical Development, and Clinical teams to ensure regulatory strategies align with scientific and compliance requirements. The role also provides an opportunity to influence global regulatory strategy across the FDA, EMA, ANVISA, and other international jurisdictions. As an independent contributor, you will bring strong scientific writing, judgment, and organizational skills to a fast‑paced biotechnology environment. The position is remote within the United States, with San Diego preferred for candidates who are able to work locally.
Responsibilities
- Serve as a primary author and lead reviewer for CMC sections of late‑stage and commercial regulatory submissions, including BLAs, MAAs, IMPDs, INDs, amendments, supplements, and related filings.
- Author and review scientifically rigorous Module 3/CTD content covering drug substance, drug product, analytical development, manufacturing, and related CMC areas.
- Support commercial lifecycle management activities, including post‑approval submissions, CMC supplements, comparability protocols, manufacturing changes, labeling updates, and annual product reports.
- Contribute to international regulatory submissions, particularly EMA and ANVISA filings, ensuring content meets jurisdiction‑specific requirements.
- Prepare and coordinate health authority interactions, including FDA Type A/B/C meetings,