Regulatory affairs Jobs in USA

Vice President, Regulatory Affairs

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.

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.

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.

Key Responsibilities

Regulatory Strategy & Leadership

• Develop and own global regulatory strategies for all Prime Medicine programs, including gene editing (Prime Editing), cell therapy, pulmonary and combination product modalities
• 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
• Provide strategic and technical guidance on INDs, CTAs, BLAs, MAAs, and related regulatory submissions, ensuring timely and high-quality filings
• Lead the development of regulatory risk assessments and mitigation strategies across all pipeline programs
• Represent regulatory affairs in executive leadership forums, Board communications, and due diligence activities for in-licensing, collaborations, and M&A

Submissions & Interactions with Health Authorities

• Oversee preparation, review, and submission of all IND and CTA filings, ensuring scientific rigor and regulatory compliance across US, EU, and other global regions
• Lead strategy and execution for Breakthrough Therapy, RMAT, Orphan Drug, and other expedited designation requests as applicable
• Direct interactions with FDA, EMA, and other regulatory agencies on all matters including clinical holds, major objections, product labeling, and post-approval commitments
• Maintain a thorough understanding of evolving regulatory guidance for advanced medicinal therapy products (ATMPs), gene therapies, and gene-edited cell therapies

Team Building & Cross-Functional Collaboration

• Able to function in lean teams and being a hands-on operator
• Partners with CMC, Clinical, Nonclinical, Program Management and Manufacturing teams to integrate regulatory strategy into all stages of program development
• Champion and drive cross-functional regulatory readiness, including preparation for pre-BLA meetings, advisory committee meetings, and inspection readiness activities
• Provide regulatory oversight and guidance for CMO/CRO activities, ensuring regulatory compliance throughout the supply and clinical development chain
• Manage regulatory consultants and CROs

Regulatory Intelligence & Compliance

• Monitor and interpret evolving global regulatory requirements, guidance, and precedents relevant to gene editing, cell therapy, and rare/genetic disease programs
• Champion continuous process improvements in regulatory operations, submission quality, and knowledge management
• Maintain compliance with ICH guidelines and all applicable regional regulatory requirements

Key Requirements

Education

• Bachelor's degree in a scientific discipline required; and advanced degree (PhD, PharmD, or MD) strongly preferred

Experience

• 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
• Minimum 5+ years of leadership experience in a global regulatory affairs role, with demonstrated success managing teams
• Significant experience in gene therapy, gene editing, cell therapy, or other advanced medicinal therapy products (ATMPs) is strongly preferred
• Experience working in rare and orphan disease, and familiar with unique regulatory frameworks guiding development in this therapeutic area.
• Demonstrated track record of successful IND and CTA submissions for novel modalities, including experience with CBER-regulated programs
• Demonstrated track record of successful BLA, NDA, and/or MAA submissions, including driving regulatory strategy and critical submission activities within expedited timelines across US and international regions.
• Prior experience engaging with FDA (CBER preferred), EMA, and other global health authorities on complex regulatory questions
• Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways is highly desirable
• Is enthusiastic about keeping up with regulatory guidance and the changing environment and putting into practice those updates

Skills & Competencies

• Exceptional strategic thinking with the ability to translate complex scientific and regulatory challenges into clear, actionable regulatory plans
• Hands-on mentality, with ability to work in a very lean environment and willingness to generate regulatory content when necessary.
• Comfort and experience managing contract research organizations.
• Strong leadership presence with proven ability to build, develop, and inspire high-performing teams in a dynamic, fast-paced environment
• Excellent negotiation, communication, and interpersonal skills; ability to represent Prime Medicine credibly before regulatory agencies and external partners
• Proven ability to work cross-functionally and influence without authority across Research, CMC, Clinical, and Commercial functions
• Demonstrated ability to manage multiple programs simultaneously, prioritize effectively, and deliver results on schedule
• Entrepreneurial mindset and comfort operating in an innovative, science-driven, start-up/growth-stage environment
• Ability and willingness to travel domestically and internationally as needed

What We Offer

• Competitive base salary commensurate with experience
• Performance-based annual bonus eligibility
• Equity participation (stock options) reflects our commitment to shared success
• Comprehensive benefits package including medical, dental, vision, 401(k), and more
• A collaborative, mission-driven culture at the forefront of genetic medicine innovation
• The opportunity to shape the regulatory function of a leading gene editing company at a pivotal stage of growth

US citizenship or valid work authorization required

Prime Medicine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.