---
title: 'Senior Manager, Regulatory Operations at Prime Medicine'
canonical: 'https://feeny.ai/job/senior-manager-regulatory-operations-prime-medicine-cambridge-ykf9exd6d3js'
type: 'job'
last_seen: '2026-10-15'
---

# Senior Manager, Regulatory Operations at Prime Medicine

- **Company:** Prime Medicine
- **Location:** Cambridge, MA
- **Compensation:** $149k–$166k
- **Posted:** 2026-10-07
- **Last confirmed live:** 2026-10-15
- **Apply:** https://job-boards.greenhouse.io/primemedicine/jobs/6219243004

## Job description

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](http://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.

## About Prime Medicine

## Company Overview
- **One-liner**: Prime Medicine is a biotechnology company using prime editing, a next-generation gene editing technology, to “search and replace” disease-causing genetic mutations and restore normal gene function.
- **Entity Type**: Public (NASDAQ: PRME, IPO October 2022)
- **Headquarters**: Cambridge, Massachusetts, United States
- **Founded**: 2019
- **Founders**: David Liu, PhD (Scientific Founder); Andrew Anzalone, MD, PhD (Co-founder)

## Core Business
- **Primary industry**: Biotechnology / Gene Editing Therapeutics
- **Target customers**: Patients with genetic diseases; partners include pharmaceutical companies (e.g., Bristol Myers Squibb) and foundations (e.g., Cystic Fibrosis Foundation)
- **Mission**: “To bring the promise of gene editing to patients” and ultimately “cure, halt, and prevent genetic diseases, providing lifelong benefit to patients.”

## Products & Services
- **Prime Editing Platform**: A proprietary gene editing technology that acts like a “DNA word processor” to precisely replace faulty DNA sequences without causing double-strand breaks. Designed to address ~90% of known disease-causing mutations.
- **PM359** (Phase 1/2): Ex vivo prime editing therapy for p47phox Chronic Granulomatous Disease (CGD). Received FDA RMAT designation and orphan drug designation.
- **PM577a** (Phase 1/2): In vivo prime editing therapy for H1069Q-mutated Wilson Disease. Clinical trial application cleared in New Zealand.
- **Alpha-1 Antitrypsin Deficiency (AATD)**: Discovery-stage liver program using LNP delivery.
- **Cystic Fibrosis**: Discovery program supported by Cystic Fibrosis Foundation (up to $15M), using PASSIGE™ technology.
- **Ex vivo CAR-T** (collaboration with Bristol Myers Squibb): Strategic license and broad collaboration to develop and commercialize ex vivo T-cell prime editor products.

## Market Standing
- **Valuation/Market Cap**: $777.8 million (as of mid-2026, per LinkedIn data)
- **Key Metric**: Annual revenue $4.6 million; total funding raised ~$1.02 billion (including post-IPO equity)
- **Notable Investors/Partners**: ARCH Venture Partners, F-Prime, Bristol-Myers Squibb (corporate round $55M in 2024), Google Ventures (post-IPO equity $5M in 2025), Cystic Fibrosis Foundation
- **Growth Signals**: 
  - Clinical data for PM359 published in *The New England Journal of Medicine*; RMAT designation from FDA.
  - Headcount of 154 (down 29.4% YoY, likely reflecting strategic refocusing).
  - Active job postings: 7 (as of mid-2026), with recent uptick in quarterly postings (+40%).

## Competitive Advantages
- **Prime Editing differentiation**: Unlike CRISPR, prime editing does not require double-strand DNA breaks, enabling more precise and predictable edits with fewer unwanted modifications.
- **Broad applicability**: Can theoretically correct ~90% of known disease-causing mutations across many organs and cell types.
- **Strong IP and scientific foundation**: Co-invented by David Liu (Broad Institute), a pioneer in gene editing.

## Strategic Focus
- **Advancing lead programs** (PM359 for CGD, PM577a for Wilson Disease) through clinical development and regulatory approvals.
- **Expanding pipeline** in liver, lung, hematology/immunology/oncology via internal research and strategic partnerships (e.g., BMS for CAR-T).
- **Leveraging delivery technologies** (LNP, AAV, ex vivo electroporation) to enable both in vivo and ex vivo applications.

## Why Work Here
- **Mission-driven culture**: Opportunity to shape the future of gene editing and directly impact patients with genetic diseases.
- **Collaborative environment**: Emphasis on diversity of viewpoints, scientific curiosity, and passion for patient outcomes.
- **Location**: Headquarters in Cambridge, MA – a hub for biotech innovation. Presence also in India.
- **Career development**: Roles span research, clinical, technical development, finance, HR, and informatics. Recent job postings include AI & Informatics Engineer, Senior Scientist, and Director of People & Culture.
- **Perks & culture**: Not explicitly detailed, but the company values “dedicated, scientifically curious individuals” and offers the chance to work with a world-class scientific team.

## Sources
1. [primemedicine.com](https://primemedicine.com/)
2. [primemedicine.com/about/](https://primemedicine.com/about/)
3. [primemedicine.com/careers/](https://primemedicine.com/careers/)
4. [primemedicine.com/pipeline/](https://primemedicine.com/pipeline/)
5. [linkedin.com/company/prime-medicine](https://www.linkedin.com/company/prime-medicine)

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