Manager, Regulatory Operations and Publishing

Role: Manager of Regulatory Operations and Publishing supporting electronic submission processes within the regulatory department of a biopharma company specializing in radiopharmaceutical therapies for cancer. Responsibilities include managing daily regulatory submission activities, formatting complex documents to comply with eCTD standards, ensuring accuracy through technical QC, coordinating with external vendors, and maintaining submission systems like Veeva Vault RIM. Requirements: Bachelor's degree with 4+ years of regulatory operations experience; proficiency in Microsoft Word formatting, PDF publishing, and familiarity with eCTD submission structure; experience with Accenture StartingPoint Templates and Veeva RIM preferred. High-Value: Focus on regulatory document management, electronic submission standards, and cross-functional collaboration across Clinical, Nonclinical, CMC, and Quality teams. Work setup: Remote location; no travel specified.