Senior Manager, Regulatory Operations

The role

The Senior Manager, Regulatory Operations will plan, coordinate, and drive execution of regulatory submissions and program timelines. This person will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure submissions to global health authorities are complete and delivered on schedule.

What you will do

• 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 and coordinate timely, well-organized responses across functional teams.
• Manage regulatory publishing and document management systems to meet eCTD and other technical standards.
• Maintain regulatory operations SOPs and tracking systems and implement process improvements.
• 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.

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.
• Experience working with global (ex-US) health agencies, such as the EMA, MHRA, Health Canada, Swissmedic, or PMDA.

Benefits

• Medical
• Dental
• Vision
• Life insurance
• 401(k) match
• Equity programs
• Generous paid time off
• Wellness days
• Company-wide recharge breaks

About the company

Prime Medicine is a biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The company leverages its proprietary Prime Editing platform to develop a new class of differentiated, one-time, potentially curative genetic therapies.