Global Regulatory Strategy Director - NDA & FDA Leadership

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 225,000 - 275,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental plan

Vision plan

Life insurance

Paid time off

Wellness program

Job summary

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Senior Director, Global Regulatory Strategy in the US to lead strategic regulatory activities across development programs, including NDA planning and submissions.

Reporting to the VP of Regulatory and Medical Writing, you will guide cross-functional teams and mentor staff, interfacing with FDA and other health authorities while ensuring lifecycle management and compliance.

Qualifications

• Bachelor's degree in a scientific discipline; 12+ years in regulatory affairs, including 5+ years in global leadership.
• Advanced degree (PhD, PharmD, MS, or JD) preferred; experience supporting small molecule development advantageous.
• Significant NDA leadership experience, including strategy, submission, and regulatory review in a sponsor environment.
• Recent experience with regulatory submission strategy, including NDAs, INDs, CTAs, and global filings.

Responsibilities

• Serve as Global Regulatory Lead for development programs across early development to registration.
• Develop and execute global regulatory strategies to obtain and expand product registrations across regions.
• Lead planning, preparation, and submission of major regulatory filings (INDs, NDAs, briefing documents).
• Represent the company in regulatory interactions; lead meetings with FDA and international agencies.
• Mentor regulatory staff and oversee external consultants and vendors; drive regulatory excellence.

Skills

Global regulatory leadership

Regulatory strategy

FDA interactions

Cross-functional leadership

Communication skills

People management

Education

Bachelor's degree in a scientific discipline

Advanced degree (PhD, PharmD, MS, or JD)

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, seeks a Senior Director, Global Regulatory Strategy in the US to lead strategic regulatory activities across development programs, including NDA planning and submissions.

Reporting to the VP of Regulatory and Medical Writing, you will guide cross-functional teams and mentor staff, interfacing with FDA and other health authorities while ensuring lifecycle management and compliance.