Actively participate in RA CMC infra-structure and capability
- Lead 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.
- Lead 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
- Manage timely regulatory submissions that involve CMC components including CTAs/INDs, NDA/MAA, and agency meeting packages.
- Provide support to regulatory interactions on CMC related topics.
| || |