Manager, Regulatory Operations and Publishing

Role: Manager of Regulatory Operations and Publishing supporting regulatory submissions for RayzeBio, a Bristol Myers Squibb subsidiary focused on radiopharmaceuticals in oncology. Responsibilities: oversee daily submission activities ensuring compliance and timeliness; format, generate, and QC submission documents according to eCTD and regulatory standards; coordinate with external vendors and internal teams (Regulatory Affairs, Clinical, Nonclinical, CMC, Quality) to support submission readiness; manage reference systems like Veeva Vault RIM; develop and improve SOPs and templates; maintain knowledge of FDA, ICH, and electronic submission standards. Requirements: Bachelor's degree; 4+ years of Regulatory Operations experience; proficiency in Word, PDF publishing, eCTD structure, and regulatory document standards; experience with Veeva RIM and Accenture StartingPoint preferred. Skills: detail-oriented, strong organizational and troubleshooting abilities, effective communicator, independent worker, collaborative mindset. High-Value: regulatory submission expertise in oncology radiopharmaceuticals, focus on electronic submission standards, cross-functional collaboration, remote work setup.