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

Role: Senior Scientist (Regulatory CMC) specializing in synthetic moieties of ADCs and bioconjugates, providing regulatory leadership across development and post-approval stages. Responsibilities: develop and implement global, phase-appropriate CMC strategies for drug-linkers, payloads, and chemically synthesized bio-conjugates; manage regulatory documentation including INDs, BLAs, and post-approval submissions; assess global regulatory requirements, identify risks, and align dossier content with development teams; oversee change controls and ensure compliance. Qualifications: BS in Chemistry, Chemical Engineering, or Biochemistry; minimum 5 years in regulatory CMC or pharmaceutical development of small molecules or chemically synthesized modalities, including process chemistry, analytical development, or manufacturing; experience supporting regulatory submissions and liaising with external partners preferred. HighValue: expertise in ADCs, drug-linkers, payloads, and bio-conjugates; involvement in global regulatory strategy, lifecycle management, and compliance; strong knowledge of GxP and regulatory documentation; hybrid work setup with no travel requirement.