Prime Medicine

Develops Prime Editing gene therapies

Vice President Regulatory Affairs

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeCambridge, MA, USA

About the Job

Requirements

A bachelor's degree in a scientific discipline is required; an advanced degree (PhD, PharmD, or MD) is strongly preferred.
At least 15 years of progressively responsible regulatory affairs or comparable experience in the pharmaceutical or biotechnology industry is required.
At least 5 years of leadership experience in a global regulatory affairs role, with demonstrated success managing teams, is required.
Experience in gene therapy, gene editing, cell therapy, or other advanced medicinal therapy products is strongly preferred.
Experience in rare and orphan disease and familiarity with the associated regulatory frameworks is required.
A demonstrated track record of successful IND and CTA submissions for novel modalities, including CBER-regulated programs, is required.
A demonstrated track record of successful BLA, NDA, and/or MAA submissions, including driving regulatory strategy and critical submission activities within expedited timelines across U.S. and international regions, is required.
Prior experience engaging with the FDA (CBER preferred), EMA, and other global health authorities on complex regulatory questions is required.
Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways is highly desirable.
The candidate must be able to translate complex scientific and regulatory challenges into clear, actionable regulatory plans.
The candidate must be able to work hands-on in a lean environment and generate regulatory content when necessary.
Experience managing contract research organizations is required.
The candidate must be able to build, develop, and inspire high-performing teams.
The candidate must be able to work cross-functionally and influence without authority across Research, CMC, Clinical, and Commercial functions.
The candidate must be able to manage multiple programs simultaneously, prioritize effectively, and deliver results on schedule.
The candidate must be willing and able to travel domestically and internationally as needed.
U.S. citizenship or valid U.S. work authorization is required.

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 the primary regulatory interface with the FDA (CBER/CDER), EMA, and other global health authorities; lead and manage high-stakes regulatory meetings, negotiations, and correspondence.
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.
Oversee preparation, review, and submission of all IND and CTA filings, ensuring scientific rigor and regulatory compliance across the U.S., 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 the FDA, EMA, and other regulatory agencies on 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.
Partner 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.
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.

Desired Qualifications

Significant experience in gene therapy, gene editing, cell therapy, or other advanced medicinal therapy products (ATMPs) is strongly preferred.
Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways is highly desirable.

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 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.

U.S. Pay Range 313000 - 348000 USD

About the Company

Prime Medicine

Develops Prime Editing gene therapies

Prime Medicine develops gene-editing therapies designed to treat a wide range of genetic diseases. The company utilizes a specific technology called "Prime Editing," which acts like a DNA word processor. This system can search for a specific location in the genetic code and replace a faulty segment of DNA with a corrected version, restoring normal function to the gene. Unlike earlier gene-editing methods like CRISPR-Cas9, which often create double-stranded breaks in DNA that can lead to unpredictable insertions or deletions, Prime Editing makes precise changes without breaking both strands of the DNA helix. This approach allows for more control over the final genetic sequence and reduces the risk of unintended mutations. The company’s goal is to create one-time curative treatments that can halt or prevent genetic disorders, providing lifelong health benefits to patients by addressing the root cause of their conditions at the molecular level.

Company size: 51-200
Company stage: IPO
Headquarters: Cambridge, MA
Founded: 2019

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