Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Role: Senior Scientist (R3) in Regulatory CMC Biologics, leading global regulatory strategies and project management for biological products throughout development and post-approval. Responsibilities: develop and execute robust CMC regulatory plans, manage documentation such as INDs, BLAs, and post-approval variations, ensure compliance with global agency requirements, and escalate issues as needed. Requirements: B.S. in a science or engineering field; 5+ years in Regulatory CMC, with biological or vaccine product experience preferred. High-Value: biologics, vaccines, Regulatory CMC, global product lifecycle management, regulatory documentation, compliance, experience with eCTD; hybrid work setup; US-based with potential travel.