Prime Medicine
Senior Manager, Regulatory Operations
Cambridge, MA · Senior · Full-time
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$15,154 more — $164,154 — moves this role to Level II and 2 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $164,154 would place this position at wage Level II. That figure is within the posted range, and I'd like to target it. This role classifies under "Managers, All Other" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Managers, All Other (11-9199) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- Demonstrated experience managing IND/CTA and BLA/MAA submissions from planning through filing.
- High attention to detail and a strong quality mindset.
Responsibilities
- 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.
- 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.
- Process & Compliance: Maintain regulatory operations SOPs and tracking systems; identify and implement process improvements to increase efficiency and quality.
- The Senior Manager, Regulatory Operations will plan, coordinate, and drive execution of regulatory submissions and program timelines across Prime Medicine's product pipeline.
Requirements
- 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.
- 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.
Nice 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.
- 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.
Skills
- Excellent written and verbal communication skills, with strong cross-functional collaboration and stakeholder management abilities.
Compensation
- $149,000 - $166,000 USD
- Submission Planning & Execution: Lead end-to-end planning and execution of regulatory submissions, including INDs/CTAs, BLAs/MAAs, amendments, annual reports, and briefing packages.
Benefits
- 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.
Equal opportunity
- Prime Medicine is proud to be an equal opportunity employer.
This listing is sourced directly from Prime Medicine's careers page and normalized into a canonical job model.