Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy
Eli Lilly and Company
August 30, 2026
On-site
Indianapolis, IN
Corporate Functions
Global Regulatory Lead (GRL)
Responsibilities
- Develop and execute global regulatory strategies; own the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle.
- Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice.
- Lead regulatory representation on the Global Brand Development (GBD)/global program team; remove regulatory barriers.
- Ensure local affiliate regulatory plans align to global strategy (labeling, risk management, issues management).
- Oversee US FDA submissions and interactions (INDs, NDAs, BLAs); drive high-quality FDA communications.
- Build productive relationships with FDA to support product registration goals.
- Lead cross-functional Global Regulatory Team; foster transparent communication and continuous development.
- Represent GRA at stakeholder/governance meetings; mentor personnel and may manage direct reports.
- Build strategic relationships with external regulatory stakeholders.
- Partner with Regulatory Product Communications and Global Marketing on promotional strategy and review press/IR materials.
Qualifications
- Advanced scientific degree (PharmD, PhD) + 8+ years regulatory affairs/drug development.
- OR Bachelor’s/Master’s + 10+ years regulatory affairs/drug development.
Preferred
- Global regulatory knowledge; submissions across US/EU/China/Japan.
- Experience in clinical and CMC regulatory sciences; strong leadership/negotiation/exec communication; risk management; therapeutic area experience.
Location/Info
- Indianapolis, IN; relocation provided; remote not available; travel 10–15%.
Benefits
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Compensation
- Anticipated wage: $169,500–$248,600.
Application instruction (accommodation)
- If you need accommodation, complete: https://careers.lilly.com/us/en/workplace-accommodation.
Responsibilities
- Develop and execute global regulatory strategies; own the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle.
- Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice.
- Lead regulatory representation on the Global Brand Development (GBD)/global program team; remove regulatory barriers.
- Ensure local affiliate regulatory plans align to global strategy (labeling, risk management, issues management).
- Oversee US FDA submissions and interactions (INDs, NDAs, BLAs); drive high-quality FDA communications.
- Build productive relationships with FDA to support product registration goals.
- Lead cross-functional Global Regulatory Team; foster transparent communication and continuous development.
- Represent GRA at stakeholder/governance meetings; mentor personnel and may manage direct reports.
- Build strategic relationships with external regulatory stakeholders.
- Partner with Regulatory Product Communications and Global Marketing on promotional strategy and review press/IR materials.
Qualifications
- Advanced scientific degree (PharmD, PhD) + 8+ years regulatory affairs/drug development.
- OR Bachelor’s/Master’s + 10+ years regulatory affairs/drug development.
Preferred
- Global regulatory knowledge; submissions across US/EU/China/Japan.
- Experience in clinical and CMC regulatory sciences; strong leadership/negotiation/exec communication; risk management; therapeutic area experience.
Location/Info
- Indianapolis, IN; relocation provided; remote not available; travel 10–15%.
Benefits
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits.
Compensation
- Anticipated wage: $169,500–$248,600.
Application instruction (accommodation)
- If you need accommodation, complete: https://careers.lilly.com/us/en/workplace-accommodation.