Associate Director of Regulatory Affairs, CMC

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Director of Regulatory Affairs, CMC based in United States.

This senior regulatory role will support 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.