Associate Director, CMC Regulatory Affairs

The Associate Director, CMC Regulatory Affairs provides strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs for small molecule drug products. This role leads the development and execution of CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management, with a primary emphasis on oral solid dosage forms. The position serves as the primary CMC Regulatory Affairs representative on cross-functional teams, driving global submissions and leading Health Authority interactions to ensure successful product approvals.