Manager, Regulatory Operations

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    "description": "<h2>Overview</h2>\n<p>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.</p>\n<h2>Responsibilities</h2>\n<ul>\n <li>CRO & Publishing Oversight: Manage external vendors to ensure the high-quality, timely publishing and submission of regulatory dossiers (e.g., IND, DSUR, NDA, etc).</li>\n <li>Regulatory Archiving: Maintain the official regulatory record by archiving all filings and health authority correspondence to ensure audit and inspection readiness.</li>\n <li>Document Preparation & Formatting: Lead the preparation of submission-ready documents, ensuring strict adherence to PDF standards, including bookmarks, hyperlinks, headers/footers, and accessibility requirements.</li>\n <li>Ensure all submission components meet global technical standards, including PDF/A compliance, OCR/searchability, and file size limitations.</li>\n <li>Serve as the Subject Matter Expert (SME) for eCTD templates, providing cross-functional guidance and training to ensure document consistency.</li>\n <li>Oversee regulatory databases and tracking for agency commitments while leading the development of SOPs, work instructions, and other controlled documents.</li>\n <li>Additional duties and responsibilities as required.</li>\n</ul>\n<h2>Qualifications</h2>\n<ul>\n <li>5+ years of experience in Regulatory Operations within Pharmaceutical or biotech industry.</li>\n <li>Comprehensive knowledge and experience of eCTD submissions, US and global health authorities</li>\n <li>Deep understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking</li>\n <li>Expert-level knowledge of eCTD software and enterprise document management systems, RIM platforms (e.g., Veeva).</li>\n</ul>",
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