Manager, Regulatory Affairs Operations

Role: Manager of Regulatory Affairs Operations focusing on global regulatory submissions, primarily U.S. FDA filings such as BLAs and INDs. Responsibilities: develop and manage submission content plans, coordinate and lead submission workflows, ensure quality and compliance, oversee RIMS documentation, and monitor regulatory intelligence; support vendor management and process optimization, including Veeva RIM adoption. Requirements: Bachelor’s in biochemistry, chemistry, biology, or related field; 3-5 years of biotech/pharma regulatory experience, with biologics focus preferred; experience with U.S. FDA submissions, eCTD standards, and RIMS (Veeva RIM). HighValue: biologics, U.S. regulatory submissions, BLA/IND, ePublishing, RIMS (Veeva RIM). WorkSetup: hybrid Warren, NJ (3 days onsite); no travel specified.