VP, Regulatory Affairs
primemedicine
30 days ago
Full-time
On-site
Cambridge, MA
$313,000 - $348,000 USD yearly
Operations
Moneyboard classification: Published base at/above threshold
Reported USD annual base: $313,000–$348,000
Original source: Greenhouse
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.
Reported USD annual base: $313,000–$348,000
Original source: Greenhouse
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.