Associate Director Regulatory Affairs CMC

Description

We're looking for an Associate Director Regulatory Affairs CMC , working in the Pharmaceuticals and Medical Products industry in Cambridge, Massachusetts, United States .

Responsibilities:

1. Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance, working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program and company goals.
2. Leads preparation, including driving strategy and content of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management.
3. Manages timely regulatory submissions that involve CMC components including CTAs/INDs, NDA/MAA, and agency meeting packages.
4. Provides support to regulatory interactions on CMC related topics.
5. Actively participates in RA CMC infrastructure and capability.