Senior Director, Regulatory Affairs, CMC

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

As Senior Director, Regulatory Affairs, CMC, you will lead global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for an innovative oncology portfolio, with a particular focus on antibody-drug conjugates (ADCs). You will serve as the Global Regulatory Lead for a late-stage program progressing toward Biologics License Application (BLA) submission, overseeing regulatory planning, execution, and health authority interactions. This strategic leadership role combines scientific expertise, regulatory excellence, and people management to advance complex therapies through development, registration, commercialization, and lifecycle management. You will lead a U.S.-based team while coordinating with global, cross-functional stakeholders across manufacturing, quality, supply chain, clinical development, and regulatory affairs. By anticipating regulatory risks and ensuring high-quality submissions, you will help accelerate development timelines and maintain compliance across a dynamic product portfolio. This is an opportunity to influence global regulatory strategy and contribute to making innovative cancer treatments more accessible to patients worldwide.