ASSOCIATE PRINCIPAL SCIENTIST REGULATORY CMC - BIOLOGICS (R4)-SYNTHETIC MOIETIES (DRUG-LINKER) OF ADCs AND BIOCONJUGATES
Core
Lead Regulatory CMC strategies for synthetic moieties (drug-linkers) of Antibody Drug Conjugates (ADCs) and bioconjugates from IND through post-approval.
Role type
Associate Principal Scientist (Regulatory CMC Lead)
Builds
Regulatory filings (IND/BLA/MAA) and dossier content for ADC and bioconjugate programs.
Domain
Biopharmaceuticals / Antibody Drug Conjugates / Synthetic Chemistry
Deliverable
client delivery
Required skills
Regulatory CMC, Chemistry, Biologics, Biologics License Application (BLA), Investigational New Drug, Pharmaceutical Process Development, Analytical Chemistry, Drug Formulations, Global Coordination, International Regulatory Compliance, Electronic Common Technical Document (eCTD)
Preferred skills
ADC development, External Manufacturing, Global life-cycle management
Responsibilities
Develop global Regulatory CMC strategies for drug-linkers and payloads; Integrate regulatory strategy for synthetic moieties with targeting components and conjugation processes; Manage preparation of CMC documentation including IND/BLA and post-approval variations; Conduct global regulatory assessments and risk identification; Collaborate on authoring and reviewing submissions for compliance and accuracy.
Seniority
Senior, hands-on IC with leadership responsibilities
