OverviewMonte 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 training to ensure document consistency.
- Oversee regulatory databases and tracking for agency commitments while leading the development of SOPs, work instructions, and other controlled documents.
- Additional duties and responsibilities as required.
Qualifications
- 5+ years of experience in Regulatory Operations within Pharmaceutical or biotech industry.
- Comprehensive knowledge and experience of eCTD submissions, US and global health authorities
- Deep understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking
- Expert-level knowledge of eCTD software and enterprise document management systems, RIM platforms (e.g., Veeva).
