Manager, Regulatory Operations

Job description

Overview Monte Rosa Therapeutics is seeking a highly skilled Regulatory Operations Manager to join our team. The ideal candidate brings expert proficiency in eCTD submissions, vendor oversight, and document management standards. This role requires a proven ability to manage multiple concurrent submission activities while maintaining precision and speed in a fast-paced environment. Responsibilities: - CRO & Publishing Oversight: Manage external vendors to ensure the high-quality, timely publishing and submission of regulatory dossiers (e.g., IND, DSUR, NDA, etc). - Regulatory Archiving: Maintain the official regulatory record by archiving all filings and health authority correspondence to ensure audit and inspection readiness. - Document Preparation & Formatting: Lead the preparation of submission-ready documents, ensuring strict adherence to PDF standards, including bookmarks, hyperlinks, headers/footers, and accessibility requirements. - Ensure all submission components meet global technical standards, including PDF/A compliance, OCR/searchability, and file size limitations. - Serve as the Subject Matter Expert (SME) for eCTD templates, providing cross-functional guidance and trai...