VP, Regulatory Affairs
Prime Medicine, a leading biotechnology company specializing in gene editing therapies, is seeking a Vice President of Regulatory Affairs to lead and mentor its regulatory affairs function. This pivotal role involves shaping global regulatory strategies from early development through BLA/MAA submission, ensuring compliance and facilitating the advancement of Prime Medicine's innovative gene editing programs.
The Vice President will develop and oversee global regulatory strategies for all Prime Medicine programs, including gene editing, cell therapy, pulmonary, and combination product modalities. Serving as the primary regulatory interface with the FDA (CBER/CDER), EMA, and other global health authorities, the role entails leading high-stakes regulatory meetings, negotiations, and correspondences. Responsibilities also include providing strategic and technical guidance on INDs, CTAs, BLAs, MAAs, and related regulatory submissions, ensuring timely and high-quality filings, and leading the development of regulatory risk assessments and mitigation strategies across all pipeline programs.
Candidates should possess a Bachelor's degree in a scientific discipline, with an advanced degree (PhD, PharmD, or MD) strongly preferred. A minimum of 15 years of progressively responsible regulatory affairs experience in the pharmaceutical or biotechnology industry is required, with at least 5 years in a global regulatory affairs leadership role. Significant experience in gene therapy, gene editing, cell therapy, or other advanced medicinal therapy products is strongly preferred. The ideal candidate will have a proven track record of successful IND and CTA submissions for novel modalities, including experience with CBER-regulated programs, and familiarity with RMAT, Breakthrough Therapy, and Orphan Drug designation pathways.
The compensation package includes a competitive base salary ranging from $313,000 to $348,000 USD per year, performance-based annual bonus eligibility, equity participation (stock options), and a comprehensive benefits package encompassing medical, dental, vision, and 401(k) plans. Prime Medicine offers a collaborative, mission-driven culture at the forefront of genetic medicine innovation, providing the opportunity to shape the regulatory function of a leading gene editing company at a pivotal stage of growth.
Prime Medicine is dedicated to creating and delivering the next generation of gene editing therapies to patients. Leveraging its proprietary Prime Editing platform, the company develops a new class of differentiated, one-time, potentially curative genetic therapies. Prime Medicine is progressing a diversified portfolio of investigational therapeutic programs organized around core areas of focus: hematology, immunology & oncology, liver, and lung. The company is committed to building and mentoring a high-performing regulatory affairs function to support its innovative programs.