Global Regulatory Strategy Director — NDA & FDA Leadership

Eli Lilly and Company; Boston (MA); Remote; USD 194,000 - 398,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Comprehensive benefits

Job summary

The Senior/Executive Director, Global Regulatory Strategy at Lilly (Centessa Pharmaceuticals as part of Lilly) leads global regulatory programs, guiding strategy and submissions across regions. This role requires strong leadership, cross-functional collaboration, and direct interactions with major health authorities, including the FDA and EMA.

Remote US-based with occasional travel. As a senior regulatory leader, you will mentor staff, oversee external consultants, and drive regulatory

Qualifications

• 12+ years of progressive regulatory affairs experience in pharma/biotech.
• 5+ years in global regulatory leadership role preferred.
• Experience leading NDA strategy, submission, and reviews.
• Experience with NDA/IND/CTAs and global regulatory filings.

Responsibilities

• Serve as Global Regulatory Lead for development programs from early development through registration and lifecycle management.
• Develop and execute global regulatory strategies across regions and health authorities.
• Lead planning, preparation, and submission of major regulatory filings (INDs, NDAs, briefing documents).
• Represent the company in regulatory interactions and lead meetings with FDA, EMA, and others.
• Provide regulatory guidance to cross-functional program teams and ensure alignment with development plans.

Skills

Regulatory leadership

NDA/IND submissions

FDA/EMA interactions

Cross-functional leadership

Regulatory strategy

Education

Bachelor's degree in a scientific discipline

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

Job description

The Senior/Executive Director, Global Regulatory Strategy at Lilly (Centessa Pharmaceuticals as part of Lilly) leads global regulatory programs, guiding strategy and submissions across regions. This role requires strong leadership, cross-functional collaboration, and direct interactions with major health authorities, including the FDA and EMA.

Remote US-based with occasional travel. As a senior regulatory leader, you will mentor staff, oversee external consultants, and drive regulatory