Senior Manager, Regulatory Operations

Prime Medicine seeks a Senior Manager to oversee regulatory submission planning and execution across its gene-editing therapy pipeline. The role coordinates with cross-functional teams to ensure timely, high-quality filings to global health authorities including the FDA and EMA.

Responsibilities

• Lead planning and execution of regulatory submissions including INDs, CTAs, BLAs, MAAs, and amendments
• Develop and maintain integrated timelines, track milestones, identify risks, and drive mitigation strategies
• Coordinate across regulatory, CMC, clinical, nonclinical, and quality teams to compile and finalize submissions
• Support health authority meetings and manage information request tracking and responses
• Manage regulatory publishing systems, maintain SOPs, and implement process improvements

Requirements

• Bachelor's degree in life sciences, regulatory affairs, or related field
• 7+ years regulatory affairs or operations experience in pharma or biotech
• Demonstrated experience managing IND/CTA and BLA/MAA submissions end-to-end
• Strong knowledge of eCTD structure, regulatory publishing tools, and document management
• Project management discipline and cross-functional coordination skills
• Ability to manage timelines, identify risks, and track health authority interactions