Author, analyze, and integrate technical data (CMC, nonclinical toxicology, and preclinical efficacy) into regulatory documents, including Pre-INDs, INDs, BLAs, DSURs, and IMPDs. The Senior Manager will collaborate closely with Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Pharmacovigilance to deliver submission-ready content that is scientifically rigorous and aligned across functions.