<div class="content-intro"><p><strong>Company Overview:</strong></p> <p>Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. </p> <p>Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit <a href="http://www.primemedicine.com/">www.primemedicine.com</a>.</p></div><p><strong>POSITION SUMMARY</strong></p> <p>The Vice President, Regulatory Affairs will report to the Chief Medical Officer and will partner closely with leaders across Research, CMC, Clinical Development, and Program Management. This is a critical role that will shape regulatory global strategy from early development through BLA/ MAA submission, while building and mentoring a high-performing regulatory affairs function.</p> <p><strong>KEY RESPONSIBILITIES</strong></p> <p><strong>Regulatory Strategy & Leadership</strong></p> <ul> <li>Develop and own global regulatory strategies for all Prime Medicine programs, including gene editing (Prime Editing), cell therapy, pulmonary and combination product modalities</li> <li>Serve as the primary regulatory interface with the FDA (CBER/CDER), EMA, and other global health authorities; lead and manage high-stakes regulatory meetings, negotiations, and correspondences</li> <li>Provide strategic and technical guidance on INDs, CTAs, BLAs, MAAs, and related regulatory submissions, ensuring timely and high-quality filings</li> <li>Lead the development of regulatory risk assessments and mitigation strategies across all pipeline programs</li> <li>Represent regulatory affairs in executive leadership forums, Board communications, and due diligence activities for in-licensing, collaborations, and M&A</li> </ul> <p><strong> </strong></p> <p><strong>Submissions & Interactions with Health Authorities</strong></p> <ul> <li>Oversee preparation, review, and submission of all IND and CTA filings, ensuring scientific rigor and regulatory compliance across US, EU, and other global regions</li> <li>Lead strategy and execution for Breakthrough Therapy, RMAT, Orphan Drug, and other expedited designation requests as applicable</li> <li>Direct interactions with FDA, EMA, and other regulatory agencies on all matters including clinical holds, major objections, product labeling, and post-approval commitments</li> <li>Maintain a thorough understanding of evolving regulatory guidance for advanced medicinal therapy products (ATMPs), gene therapies, and gene-edited cell therapies</li> </ul> <p> </p> <p><strong>Team Building & Cross-Functional Collaboration</strong></p> <ul> <li>Able to function in lean teams and being a hands-on operator</li> <li>Partners with CMC, Clinical, Nonclinical, Program Management and Manufacturing teams to integrate regulatory strategy into all stages of program development</li> <li>Champion and drive cross-functional regulatory readiness, including preparation for pre-BLA meetings, advisory committee meetings, and inspection readiness activities</li> <li>Provide regulatory oversight and guidance for CMO/CRO activities, ensuring regulatory compliance throughout the supply and clinical development chain</li> <li>Manage regulatory consultants and CROs</li> </ul> <p> </p> <p><strong>Regulatory Intelligence & Compliance</strong></p> <ul> <li>Monitor and interpret evolving global regulatory requirements, guidance, and precedents relevant to gene editing, cell therapy, and rare/genetic disease programs</li> <li>Champion continuous process improvements in regulatory operations, submission quality, and knowledge management</li> <li>Maintain compliance with ICH guidelines and all applicable regional regulatory requirements</li> </ul> <p> </p> <p><strong>KEY REQUIREMENTS</strong></p> <p><strong>Education</strong></p> <ul> <li>Bachelor's degree in a scientific discipline required; and advanced degree (PhD, PharmD, or MD) strongly preferred</li> </ul> <p> </p> <p><strong>Experience</strong></p> <ul> <li>Minimum 15+ years of progressively responsible regulatory affairs or comparable experience in the pharmaceutical or biotechnology industry, gene/ cell/ novel platform therapy will be preferred</li> <li>Minimum 5+ years of leadership experience in a global regulatory affairs role, with demonstrated success managing teams</li> <li>Significant experience in ge