VP, Regulatory Affairs

The role

The Vice President, Regulatory Affairs will shape global regulatory strategy from early development through BLA/MAA submission. This person will build and mentor a regulatory affairs function and partner with leaders in Research, CMC, Clinical Development, and Program Management.

What you will do

• Develop and own global regulatory strategies for all Prime Medicine programs
• Serve as the primary regulatory interface with the FDA, EMA, and other global health authorities
• Provide strategic and technical guidance on INDs, CTAs, BLAs, MAAs, and related regulatory submissions
• Lead the development of regulatory risk assessments and mitigation strategies
• Represent regulatory affairs in executive leadership forums, Board communications, and due diligence activities
• Oversee preparation, review, and submission of all IND and CTA filings
• Lead strategy and execution for Breakthrough Therapy, RMAT, Orphan Drug, and other expedited designation requests
• Direct interactions with FDA, EMA, and other regulatory agencies
• Partner with CMC, Clinical, Nonclinical, Program Management and Manufacturing teams
• Manage regulatory consultants and CROs

Required qualifications

• Bachelor's degree in a scientific discipline
• Minimum 15+ years of progressively responsible regulatory affairs or comparable experience in the pharmaceutical or biotechnology industry
• Minimum 5+ years of leadership experience in a global regulatory affairs role
• Experience working in rare and orphan disease
• Demonstrated track record of successful IND and CTA submissions for novel modalities
• Demonstrated track record of successful BLA, NDA, and/or MAA submissions
• Prior experience engaging with FDA and EMA on complex regulatory questions
• Ability to travel domestically and internationally as needed

Nice to have

• Advanced degree (PhD, PharmD, or MD)
• Gene/ cell/ novel platform therapy experience
• Significant experience in gene therapy, gene editing, cell therapy, or other advanced medicinal therapy products (ATMPs)
• Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways
• Experience with CBER-regulated programs

Benefits

• Competitive base salary
• Performance-based annual bonus eligibility
• Equity participation (stock options)
• Medical, dental, and vision
• 401(k) and 401(k) match
• Life insurance
• Generous paid time off
• Wellness days
• Company-wide recharge breaks

Before you apply

• US citizenship or valid work authorization required

About the company

Prime Medicine is a biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients using its proprietary Prime Editing platform.