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VP, Regulatory Affairs

Prime Medicine· Regulatory Affairs
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Cambridge, MA$313k - $348kfull-timePosted 2w ago

About the role

Vice President, Regulatory Affairs responsible for global regulatory strategy and leadership across Prime Medicine’s gene editing, cell therapy, and related modalities, from early development through regulatory submissions, building and mentoring a regulatory affairs function.

Responsibilities

  • 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 primary regulatory interface with the FDA (CBER/CDER), EMA, and other global authorities; lead regulatory meetings, negotiations, and correspondences
  • Provide strategic and technical guidance on INDs, CTAs, BLAs, MAAs, and related submissions
  • Lead regulatory risk assessments and mitigation strategies across pipeline programs
  • Represent regulatory affairs in executive leadership forums, Board communications, and due diligence for in-licensing, collaborations, and M&A
  • Oversee preparation, review, and submission of INDs and CTAs across US, EU, and other regions
  • Lead strategy for Breakthrough Therapy, RMAT, Orphan Drug, and other expedited designations
  • Direct interactions with regulators on clinical holds, objections, labeling, and post-approval commitments
  • Maintain understanding of evolving guidance for ATMPs, gene therapies, and gene-edited cell therapies
  • Function in lean teams; hands-on operator; partner with CMC, Clinical, Nonclinical, Program Management, and Manufacturing
  • Drive regulatory readiness for pre-BLA meetings, advisory committees, and inspection readiness
  • Provide regulatory oversight for CMO/CRO activities and manage consultants/CROs
  • Monitor and interpret evolving global regulatory requirements; champion process improvements in regulatory operations
  • Maintain compliance with ICH and regional regulations

Qualifications

  • Bachelor’s degree in a scientific discipline required; advanced degree (PhD, PharmD, or MD) strongly preferred
  • Minimum 15+ years in regulatory affairs or equivalent in pharma/biotech, with gene/cell/novel platform therapy preferred
  • Minimum 5+ years of global regulatory affairs leadership experience with proven team management
  • Significant experience in gene therapy, gene editing, cell therapy, or ATMPs preferred
  • Experience with rare/orphan disease regulatory frameworks
  • Track record of successful IND and CTA submissions for novel modalities (CBER experience preferred)
  • Track record of successful BLA/NDA/MAA submissions and expedited timelines for US and international regions
  • Experience engaging with FDA (CBER preferred), EMA, and other global authorities on complex questions
  • Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways desirable
  • Commitment to staying up-to-date with regulatory guidance

Skills

Required:Strategic regulatory planningRegulatory submission leadershipRegulatory agency negotiations

Benefits

  • Competitive base salary
  • Performance-based annual bonus eligibility
  • Equity participation (stock options)
  • Comprehensive benefits package (medical, dental, vision, 401(k), etc.)
  • Collaborative, mission-driven culture
  • Total Rewards package including health, financial, and wellness benefits
  • Paid time off, wellness days, and recharge breaks
Last updated Oct 7, 2026. Interested? Apply on the company site.

About Prime Medicine

Delivering on the promise of Prime Editing

Prime Medicine™ was founded with a goal of transforming the lives of patients with debilitating diseases through the application of our groundbreaking Prime Editing platform and technology.

next- generation gene editingPrime Editinggene editingtherapeutic applications
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