Manager, Regulatory Affairs Operations

Role: Manager of Regulatory Affairs Operations, focusing on U.S. FDA submissions for biologics at a mid-stage biopharma company. Responsibilities include developing global submission content plans, coordinating and executing regulatory filings (e.g., BLAs, INDs), ensuring compliance and quality, and managing submission documentation within RIMS systems like Veeva RIM. The role involves monitoring evolving regulatory trends, supporting vendor management, and ensuring timely, high-quality submissions. Qualifications: Bachelor’s degree in biochemistry, chemistry, biology, or related field; 3-5 years of biotech/pharma regulatory experience, preferably with biologics and U.S. FDA submissions; deep understanding of eCTD standards and regulatory information management systems; strong project management and communication skills. Preferred: advanced degree (PhD, PharmD, MS), experience with biologics and ePublishing. High-Value: biologics, U.S. FDA (BLA, IND), eCTD, regulatory submission planning, Veeva RIM expertise, GxP compliance. Work setup: Warren, NJ, hybrid (3 days on-site). Travel not specified.