Regulatory Submissions Lead (IND/CTA)

primemedicine; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Prime Medicine, based in Cambridge, MA, seeks a Senior Manager, Regulatory Operations to plan and drive regulatory submissions across its product pipeline. You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure timely, high-quality filings to FDA and global authorities.

The role requires strong project management, deep knowledge of eCTD publishing, and a proven ability to keep cross-functional teams aligned under tight timelines.

Qualifications

• Bachelor's degree in life sciences, regulatory affairs, or related field.
• 7+ years in regulatory affairs or regulatory operations.
• Experience managing IND/CTA and BLA/MAA submissions.
• Knowledge of eCTD structure, publishing tools, and document management systems (e.g., Veeva Vault).
• Strong project management, with ability to manage multiple programs and priorities.
• Excellent written and verbal communication with cross-functional collaboration.

Responsibilities

• Lead end-to-end planning and execution of regulatory submissions (INDs/CTAs, BLAs/MAAs, amendments, annual reports).
• Maintain integrated regulatory timelines, track milestones, identify risks, and drive mitigations.
• Coordinate content with Regulatory Affairs, CMC, Nonclinical, Clinical, Quality, and external partners.
• Support health authority meetings preparation, briefing books, logistics, and minutes.
• Track health authority information requests and coordinate timely responses.
• Manage regulatory publishing and document management systems (eCTD).
• Identify and implement process improvements; manage vendors and budgets.

Skills

Project management

Cross-functional collaboration

Regulatory writing & editorial

Attention to detail

Communication skills

Education

Bachelor's degree in life sciences/regulatory affairs

7+ years regulatory affairs/operations

Advanced degree (MS/PhD) preferred

PMP or PM certification preferred

Tools

Veeva Vault RIM

eCTD publishing tools

Job description

Prime Medicine, based in Cambridge, MA, seeks a Senior Manager, Regulatory Operations to plan and drive regulatory submissions across its product pipeline. You will partner with Regulatory Affairs, CMC, Nonclinical, Clinical, and Quality teams to ensure timely, high-quality filings to FDA and global authorities.

The role requires strong project management, deep knowledge of eCTD publishing, and a proven ability to keep cross-functional teams aligned under tight timelines.