Senior Regulatory Operations Lead (Biotech)

Prime Medicine, Inc.; Cambridge (MA); Sur place; USD 149 000 - 166 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental insurance

Vision insurance

Life Insurance

401(k) match

Equity programs

Paid time off

Résumé du poste

Prime Medicine, Inc. is seeking a Senior Manager of Regulatory Operations to plan, coordinate, and drive global submissions across our product pipeline.

You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external vendors to ensure complete, high-quality submissions are delivered on schedule. The role requires strong project management and deep knowledge of regulatory submission processes across the FDA and EMA.

Qualifications

• Bachelor's degree in life sciences, regulatory affairs, or a related field is required.
• Strong project management discipline with ability to lead multiple programs.

Responsabilités

• Lead end-to-end planning and execution of regulatory submissions (INDs/CTAs, BLAs/MAAs, amendments, annual reports, briefing packages).
• Develop and maintain integrated regulatory timelines, milestones, dependencies, and risks.
• Coordinate with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partners to finalize submission content.
• Prepare for health authority meetings, including briefing books and minutes.
• Track health authority information requests and coordinate timely responses.
• Manage regulatory publishing and document management systems to meet eCTD standards.
• Maintain SOPs and implement process improvements in regulatory operations.
• Support management of regulatory vendors and budgets as needed.

Connaissances

IND/CTA submissions

BLA/MAA submissions

Project management

Cross-functional collaboration

Regulatory operations

Documentation accuracy

Formation

Bachelor's degree in life sciences/regulatory

Advanced degree (MS/PhD/PharmD)

Outils

Veeva Vault RIM

Description du poste

Prime Medicine, Inc. is seeking a Senior Manager of Regulatory Operations to plan, coordinate, and drive global submissions across our product pipeline.

You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external vendors to ensure complete, high-quality submissions are delivered on schedule. The role requires strong project management and deep knowledge of regulatory submission processes across the FDA and EMA.