New · posted Oct 15
Prime Medicine · Biotechnology
Senior Manager, Regulatory Operations
- Cambridge, MA
- On-site
- Full-time
- Manager
Open until filled
The role
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.
What you need
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 Qualificationsnice to have
- 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
What you'll do
- 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.
Pay and benefits
$149,000 – $166,000 a year
Employer providedMedical, dental, vision insurance
Life insurance
401(k) match
Equity programs
Annual bonus eligibility
Generous paid time off
Where you'll work
Cambridge, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Cambridge, MAFrom the posting
About Prime Medicine
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.
Equal opportunity, accessibility and legal noticesPrime Medicine's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% below the US median for Regulatory Operations roles at this level.
This roleEmployer provided
Manager roles in the US8 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $149,000 | — | $166,000 |
| All US (middle half) | $168,125 | $178,250 | $183,750 |
This role: Prime Medicine's own published range. Comparisons: the base pay employers published on open Regulatory Operations roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Operations
The general path across 34 open Regulatory Operations roles on Regulatory Jobs, with the titles they carry most. Not Prime Medicine's own promotion track.
Career resources on Regulatory Operations
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions8
- Collaboration and leadership6
- Documentation and SOPs4
- Quality systems and risk2
- GMP and compliance1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Prime Medicine on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 1
- Locations
By discipline
- Regulatory2 67%
- Quality1 33%
By level
- VP & Executive1 33%
- Manager1 33%
- Senior & Principal1 33%
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Senior Manager, Regulatory Operations at Prime Medicine
Open until filled. $149K–$166K a year, employer provided.