Senior Scientist, Regulatory Affairs- CMC - Synthetic Moieties of ADC's and Bioconjugates
Core
Lead Regulatory Chemistry, Manufacturing, and Control (CMC) for the synthetic moiety (drug-linker) of antibody-drug conjugate (ADC) and bioconjugate programs, ensuring compliance and milestone delivery from development through post-approval.
Role type
Senior Regulatory CMC Scientist (Synthetic Moieties)
Builds
Regulatory dossiers and submissions for ADCs and bioconjugates
Domain
Biopharmaceuticals / Antibody-Drug Conjugates
Deliverable
client delivery
Required skills
Regulatory CMC, Process Chemistry, Analytical Chemistry, Drug Formulations, eCTD, Regulatory Compliance, Change Control Management, Global Regulatory Strategy
Preferred skills
ADC development, External manufacturing partner management, Global life-cycle management
Technologies
eCTD
Responsibilities
Develop global Regulatory CMC strategies for synthetic moieties; Integrate regulatory strategy with targeting components and conjugation processes; Manage preparation of INDs, IMPDs, BLAs, and MAAs; Execute change controls and regulatory filing strategies; Lead cross-functional teams on regulatory milestones.
Seniority
Senior, hands-on IC
