Senior Regulatory Submissions Lead — Biotech

Prime Medicine, Inc.; Cambridge (MA); On-site; USD 149,000 - 166,000; Full time

Benefits offered by this job

401(k) match

Equity programs

Paid time off

Job summary

Prime Medicine, Inc. seeks a Senior Manager of Regulatory Operations to drive submissions and program timelines across its therapeutic pipeline.

You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure high-quality, on-time filings with FDA/EMA and other authorities. The ideal candidate brings deep regulatory submission experience, strong project management, and a proven ability to align cross-functional teams under tight timelines.

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.

Responsibilities

• Lead end-to-end planning and execution of regulatory submissions, including INDs/CTAs, BLAs/MAAs, amendments, annual reports, and briefing packages.
• Develop and maintain integrated regulatory timelines, track milestones and dependencies, identify critical-path risks, and drive mitigation plans.
• Partner with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partners to compile, quality-check, and finalize submission content.
• Support preparation for health authority meetings, including briefing books, logistics, meeting minutes, and action item tracking.
• Track incoming health authority information requests (IRs) and coordinate timely, well-organized responses across functional teams.
• Manage regulatory publishing and document management systems, ensuring submissions meet eCTD and other applicable technical standards.
• Maintain regulatory operations SOPs and tracking systems; identify and implement process improvements to increase efficiency and quality.
• Support management of regulatory operations vendors and budget, including publishing and translation vendors.

Skills

Project management

Regulatory submissions

Cross-functional collaboration

eCTD knowledge

Regulatory publishing tools

Vendor management

Education

Bachelor's degree in life sciences or regulatory affairs

Advanced degree (MS/PhD) preferred

Tools

Veeva Vault RIM

Regulatory publishing tools

Job description

Prime Medicine, Inc. seeks a Senior Manager of Regulatory Operations to drive submissions and program timelines across its therapeutic pipeline.

You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure high-quality, on-time filings with FDA/EMA and other authorities. The ideal candidate brings deep regulatory submission experience, strong project management, and a proven ability to align cross-functional teams under tight timelines.