Senior Scientist, Regulatory Affairs- CMC - Synthetic Moieties of ADC's and Bioconjugates

Role: Senior Scientist (R3) Regulatory CMC focusing on synthetic moieties of ADCs and bioconjugates, providing regulatory leadership across product development and lifecycle. Responsibilities: develop and implement global regulatory CMC strategies for drug-linkers, payloads, peptides, and chemically synthesized components; manage regulatory documentation including INDs, MAAs, and post-approval submissions; assess global regulatory requirements, identify risks, and ensure compliance; align regulatory strategies with manufacturing, conjugation processes, and product dossiers. Requirements: B.S. in Chemistry, Chemical Engineering, Biochemistry or related field; minimum 5 years relevant experience in pharmaceutical CMC, process chemistry, analytical development, or manufacturing with small molecules or chemically synthesized modalities; experience with regulatory submissions, global lifecycle management, and external partnerships preferred. High-Value: ADCs, bio-conjugates, drug-linkers, payloads, process chemistry, analytical development, regulatory submissions (INDs, MAAs, post-approval), GxP compliance, global regulatory strategy, hybrid work setup, no travel required.