CMC - Strategy- Assoc. Director
Cambridge Metro Area, MA
- MS or PhD preferred with a Minimum 8 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 5 years regulatory affairs experience including managing submissions and developing regulatory CMC strategy for development and/or commercial pharmaceutical or biological products.
- Sound understanding of chemistry and biology. Experience in oligonucleotides is a plus.
- Direct experience in preparation of original NDA/BLA, response to regulatory agency queries, and/or other complex submissions.
- 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