Biotechnology, Gene Therapy, Pharmaceuticals

Senior Manager, Regulatory Operations

Cambridge, MAOnsiteFull TimeManager / Head$149,000–$166,000 /yrPosted 1 month agoVisa sponsorship available

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Required skills

regulatory submissions
program timelines
INDs
CTAs
BLAs
MAAs
amendments
annual reports
briefing packages
FDA

Nice to have

rare disease
orphan drug
gene therapy
gene editing
cell therapy
Breakthrough Therapy

Role summary

Prime Medicine is seeking a Senior Manager, Regulatory Operations to lead the planning and execution of regulatory submissions for their product pipeline. This role involves close collaboration with cross-functional teams (Regulatory Affairs, CMC, Clinical, Quality) to ensure timely and high-quality submissions to global health authorities like the FDA and EMA. Responsibilities include timeline and risk management, health authority interactions, and managing regulatory systems and processes. The ideal candidate has 7+ years of experience in the pharmaceutical or biotech industry, with demonstrated success in managing IND/CTA and BLA/MAA submissions, strong project management skills, and knowledge of eCTD and publishing tools.

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 insurance, a 401(k) match, and equity programs—along with generous paid time off, wellness days, and company-wide recharge breaks.

Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together.

U.S. Pay Range$149,000—$166,000 USD

Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.

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