Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control
Listed on 2026-10-12
-
Pharmaceutical
Regulatory Compliance Specialist
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 escalat[>???] 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.
We have an opening for a Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control in Rahway, NJ, United States within Bio & Pharmacology & Health, Other.
Full responsibilities and requirements are described in the listing above.
Learn more about the Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control role in the description above.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).