Regulatory Operations Manager

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 Senior Manager, Regulatory Operations will plan, coordinate, and drive execution of regulatory submissions and program timelines across Prime Medicine's product pipeline. This role partners closely with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure submissions to global health authorities (including the FDA and EMA) are complete, high-quality, and delivered on schedule. The ideal candidate brings strong project management discipline, deep familiarity with regulatory submission processes, and the ability to keep cross-functional teams aligned under tight timelines.

Key Responsibilities

• Submission Planning & Execution: Lead end-to-end planning and execution of regulatory submissions, including INDs/CTAs, BLAs/MAAs, amendments, annual reports, and briefing packages.
• Timeline & Risk Management: Develop and maintain integrated regulatory timelines, track milestones and dependencies, identify critical-path risks, and drive mitigation plans.
• Cross-Functional Coordination: Partner with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partners to compile, quality-check, and finalize submission content.
• Health Authority Interactions: Support preparation for health authority meetings, including briefing books, logistics, meeting minutes, and action item tracking.
• Track incoming health authority information requests (IRs) and coordinate timely, well-organized responses across functional teams.