---
title: 'VP, Regulatory Affairs at Prime Medicine'
canonical: 'https://feeny.ai/job/vp-regulatory-affairs-prime-medicine-cambridge-82w65j0854bh'
type: 'job'
last_seen: '2026-10-15'
---

# VP, Regulatory Affairs at Prime Medicine

- **Company:** Prime Medicine
- **Location:** Cambridge, MA
- **Compensation:** $313k–$348k
- **Posted:** 2026-10-02
- **Last confirmed live:** 2026-10-15
- **Apply:** https://job-boards.greenhouse.io/primemedicine/jobs/6215607004

## Job description

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](http://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 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. 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.

## About Prime Medicine

## Company Overview
- **One-liner**: Prime Medicine is a biotechnology company using prime editing, a next-generation gene editing technology, to “search and replace” disease-causing genetic mutations and restore normal gene function.
- **Entity Type**: Public (NASDAQ: PRME, IPO October 2022)
- **Headquarters**: Cambridge, Massachusetts, United States
- **Founded**: 2019
- **Founders**: David Liu, PhD (Scientific Founder); Andrew Anzalone, MD, PhD (Co-founder)

## Core Business
- **Primary industry**: Biotechnology / Gene Editing Therapeutics
- **Target customers**: Patients with genetic diseases; partners include pharmaceutical companies (e.g., Bristol Myers Squibb) and foundations (e.g., Cystic Fibrosis Foundation)
- **Mission**: “To bring the promise of gene editing to patients” and ultimately “cure, halt, and prevent genetic diseases, providing lifelong benefit to patients.”

## Products & Services
- **Prime Editing Platform**: A proprietary gene editing technology that acts like a “DNA word processor” to precisely replace faulty DNA sequences without causing double-strand breaks. Designed to address ~90% of known disease-causing mutations.
- **PM359** (Phase 1/2): Ex vivo prime editing therapy for p47phox Chronic Granulomatous Disease (CGD). Received FDA RMAT designation and orphan drug designation.
- **PM577a** (Phase 1/2): In vivo prime editing therapy for H1069Q-mutated Wilson Disease. Clinical trial application cleared in New Zealand.
- **Alpha-1 Antitrypsin Deficiency (AATD)**: Discovery-stage liver program using LNP delivery.
- **Cystic Fibrosis**: Discovery program supported by Cystic Fibrosis Foundation (up to $15M), using PASSIGE™ technology.
- **Ex vivo CAR-T** (collaboration with Bristol Myers Squibb): Strategic license and broad collaboration to develop and commercialize ex vivo T-cell prime editor products.

## Market Standing
- **Valuation/Market Cap**: $777.8 million (as of mid-2026, per LinkedIn data)
- **Key Metric**: Annual revenue $4.6 million; total funding raised ~$1.02 billion (including post-IPO equity)
- **Notable Investors/Partners**: ARCH Venture Partners, F-Prime, Bristol-Myers Squibb (corporate round $55M in 2024), Google Ventures (post-IPO equity $5M in 2025), Cystic Fibrosis Foundation
- **Growth Signals**: 
  - Clinical data for PM359 published in *The New England Journal of Medicine*; RMAT designation from FDA.
  - Headcount of 154 (down 29.4% YoY, likely reflecting strategic refocusing).
  - Active job postings: 7 (as of mid-2026), with recent uptick in quarterly postings (+40%).

## Competitive Advantages
- **Prime Editing differentiation**: Unlike CRISPR, prime editing does not require double-strand DNA breaks, enabling more precise and predictable edits with fewer unwanted modifications.
- **Broad applicability**: Can theoretically correct ~90% of known disease-causing mutations across many organs and cell types.
- **Strong IP and scientific foundation**: Co-invented by David Liu (Broad Institute), a pioneer in gene editing.

## Strategic Focus
- **Advancing lead programs** (PM359 for CGD, PM577a for Wilson Disease) through clinical development and regulatory approvals.
- **Expanding pipeline** in liver, lung, hematology/immunology/oncology via internal research and strategic partnerships (e.g., BMS for CAR-T).
- **Leveraging delivery technologies** (LNP, AAV, ex vivo electroporation) to enable both in vivo and ex vivo applications.

## Why Work Here
- **Mission-driven culture**: Opportunity to shape the future of gene editing and directly impact patients with genetic diseases.
- **Collaborative environment**: Emphasis on diversity of viewpoints, scientific curiosity, and passion for patient outcomes.
- **Location**: Headquarters in Cambridge, MA – a hub for biotech innovation. Presence also in India.
- **Career development**: Roles span research, clinical, technical development, finance, HR, and informatics. Recent job postings include AI & Informatics Engineer, Senior Scientist, and Director of People & Culture.
- **Perks & culture**: Not explicitly detailed, but the company values “dedicated, scientifically curious individuals” and offers the chance to work with a world-class scientific team.

## Sources
1. [primemedicine.com](https://primemedicine.com/)
2. [primemedicine.com/about/](https://primemedicine.com/about/)
3. [primemedicine.com/careers/](https://primemedicine.com/careers/)
4. [primemedicine.com/pipeline/](https://primemedicine.com/pipeline/)
5. [linkedin.com/company/prime-medicine](https://www.linkedin.com/company/prime-medicine)

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