VP, Regulatory Affairs

The posting, as Prime Medicine wrote it

Company Overview

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. For more information, please visit www.primemedicine.com .

POSITION SUMMARY

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 und

[…]
ience-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.
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity).

Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits—including medical, dental, vision, life insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.

Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.

U.S. Pay Range
$313,000 — $348,000 USD

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.