Senior Manager, Regulatory Operations

primemedicine; Cambridge (MA); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Prime Medicine, based in Cambridge, MA, seeks a Senior Manager, Regulatory Operations to plan and drive regulatory submissions across its product pipeline. You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure timely, high-quality filings to FDA and global authorities.

The role requires strong project management, deep knowledge of eCTD publishing, and a proven ability to keep cross-functional teams aligned under tight timelines.

Qualifications

• Bachelor's degree in life sciences, regulatory affairs, or related field.
• 7+ years in regulatory affairs or regulatory operations.
• Experience managing IND/CTA and BLA/MAA submissions.
• Knowledge of eCTD structure, publishing tools, and document management systems (e.g., Veeva Vault).
• Strong project management, with ability to manage multiple programs and priorities.
• Excellent written and verbal communication with cross-functional collaboration.

Responsabilités

• Lead end-to-end planning and execution of regulatory submissions (INDs/CTAs, BLAs/MAAs, amendments, annual reports).
• Maintain integrated regulatory timelines, track milestones, identify risks, and drive mitigations.
• Coordinate content with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partners.
• Support health authority meetings preparation, briefing books, logistics, and minutes.
• Track health authority information requests and coordinate timely responses.
• Manage regulatory publishing and document management systems (eCTD).
• Identify and implement process improvements; manage vendors and budgets.

Connaissances

Project management

Cross-functional collaboration

Regulatory writing & editorial

Attention to detail

Communication skills

Formation

Bachelor's degree in life sciences/regulatory affairs

7+ years regulatory affairs/operations

Advanced degree (MS/PhD) preferred

PMP or PM certification preferred

Outils

Veeva Vault RIM

eCTD publishing tools

Description du poste

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.
• Information Requests: Track incoming health authority information requests (IRs) and coordinate timely, well-organized responses across functional teams.
• Document & Systems Management: Manage regulatory publishing and document management systems, ensuring submissions meet eCTD and other applicable technical standards.
• Process & Compliance: Maintain regulatory operations SOPs and tracking systems; identify and implement process improvements to increase efficiency and quality.
• Vendor & Budget Oversight: Support management of regulatory operations vendors and budget, including publishing and translation vendors.

Required Qualifications

• Bachelor's degree in life sciences, regulatory affairs, or a related field.
• 7+ years of experience in regulatory affairs or regulatory operations within the pharmaceutical or biotechnology industry.
• Demonstrated experience managing IND/CTA and BLA/MAA submissions from planning through filing.
• Strong working knowledge of eCTD structure, regulatory publishing tools, and document management systems (e.g., Veeva Vault RIM or similar).
• Proven project management skills, with the ability to manage multiple concurrent programs and competing priorities.
• Excellent written and verbal communication skills, with strong cross-functional collaboration and stakeholder management abilities.
• High attention to detail and a strong quality mindset.

Preferred Qualifications

• Experience supporting rare disease or orphan drug development programs.
• Experience with gene therapy, gene editing, or cell therapy regulatory submissions.
• Experience with expedited programs such as Breakthrough Therapy, Fast Track, RMAT, or Orphan Drug Designation.
• PMP or other formal project management certification.
• Advanced degree (MS, PharmD, or PhD) in a scientific discipline.
• Experience working with global (ex-US) health agencies, such as the EMA, MHRA, Health Canada, Swissmedic, or PMDA.

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 i