Vice President Regulatory Affairs
$313k - $348k+ Annual bonus + Stock options/equity
Expert
Bachelor's, PharmD, PhD, MD
Cambridge, MA, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A bachelor's degree in a scientific discipline is required.
- A minimum of 15 years of progressively responsible regulatory affairs or comparable experience in the pharmaceutical or biotechnology industry is required.
- A minimum of 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 regulatory frameworks for these therapeutic areas are required.
- A demonstrated track record of successful IND and CTA submissions for novel modalities, including experience with 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, preferably CBER, 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 role requires staying current with regulatory guidance and applying updates in a changing regulatory environment.
- The role requires the ability to work in a lean environment and generate regulatory content when necessary.
- Experience managing contract research organizations is required.
- Ability and willingness to travel domestically and internationally as needed is required.
Responsibilities
- Develop and own global regulatory strategies for all Prime Medicine programs, including gene editing, cell therapy, pulmonary, and combination product modalities.
- Serve as the primary regulatory interface with the FDA, 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 mergers and acquisitions.
- 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 applicable expedited designation requests.
- 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, 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
- An advanced degree (PhD, PharmD, or MD) is strongly preferred.
- Gene therapy, gene editing, cell therapy, or other advanced medicinal therapy product experience is strongly preferred.
- Familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways is highly desirable.
About the company
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, Massachusetts
Founded
2019
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Simplify's Take
What believers are saying
- August 6, 2026 results showed PM577a startup underway, with initial data due 2027.
- July 8, 2026 arbitration victory secured PM647 rights and removed Beam damages.
- Cash was $108.8 million on June 30, 2026, funding operations into 2027.
What critics are saying
- Cash fell from $191.4 million to $108.8 million in six months, forcing dilution.
- PM647 still needs a Q3 2026 IND, so AATD revenue arrives no earlier than 2027.
- Prime editing remains unproven commercially; a failed 2027 readout kills the platform.
What makes Prime Medicine unique
- Prime Medicine owns prime editing, enabling insert, delete, and replacement edits in one platform.
- PM577a became the first in vivo prime-editing program cleared by FDA and Medsafe.
- Its universal liver LNP supports both Wilson disease and AATD programs.
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Benefits
- Flexible Work Hours