Associate Principal Scientist, Regulatory Affairs

Role: Associate Principal Scientist, Regulatory CMC for biologics, equivalent to Associate Director, focusing on developing and implementing global regulatory strategies for biologics products, including INDs, BLAs, and post-approval changes. Responsibilities: authoring and submitting CMC sections, managing regulatory assessments and strategies, ensuring timely submissions, and collaborating across teams for compliance and scientific rigor. Requirements: B.S. in sciences (advanced degree preferred), 10+ years of biologics CMC regulatory experience, expertise with IND/BLA filings, strong understanding of manufacturing, analytical, and quality fields, and excellent communication skills. Preferred: experience with ADCs, complex dosage forms, and regulatory agency interactions. High-value details: biologics modality, global regulatory scope, early and late development stages, regulatory strategy development, and cross-functional collaboration. Work setup: hybrid model, no specific travel mentioned.