Manager, Regulatory Operations (Publishing)

Role: Senior Manager, Global Regulatory Submission Management and Publishing, leading the planning, preparation, and submission of global regulatory dossiers for Replimune’s cancer immunotherapy programs. Responsibilities include managing end-to-end submission processes, publishing INDs, BLAs, MAAs, CTIS submissions, amendments, and reports, and ensuring compliance with international regulatory standards. The role involves technical leadership in Veeva Vault RIM systems, process improvement, and cross-functional coordination with Regulatory Affairs, Medical Writing, Clinical Operations, and external vendors. Requirements: Bachelor's degree with at least 8 years' regulatory operations and publishing experience in biotech/pharma, deep knowledge of global regulatory requirements (FDA, EMA, ICH), and expert proficiency in Veeva Vault RIM, eCTD standards, and electronic submission platforms. Preferred skills include experience with SEND datasets, CTIS, StartingPoint, and Veeva PromoMats. High-value specifics: focus on biologics or oncolytic immunotherapies in clinical development stages, with emphasis on global compliance and electronic submission standards. The position is based in Woburn, MA, with a hybrid work arrangement and approximately 10% onsite attendance, with no travel expectations specified.