Role OverviewThe Senior Manager, Regulatory Operations will plan, coordinate, and drive execution of regulatory submissions and program timelines across Prime Medicine's product pipeline.
What You Will Do
Lead end-to-end planning and execution of regulatory submissions, develop and maintain integrated regulatory timelines, and partner with cross-functional teams to compile, quality-check, and finalize submission content.
Why It Might Be a Fit
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.
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.
- 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.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- 401(k) match
- Equity programs
- Paid time off
- Wellness days
- Company-wide recharge breaks
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