Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine
Eli Lilly and Company
August 21, 2026
Remote friendly (Indianapolis, IN)
United States
Corporate Functions
About The Role
As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies—from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.
Key Responsibilities
- Develop and execute innovative global regulatory strategies, owning 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 GBD/global program team; shape development plans and address regulatory barriers
- Ensure local affiliate regulatory plans align to global strategy and business priorities (labeling, risk management, issues management)
- Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs)
- Drive high-quality communications with FDA articulating scientific position
- Build relationships with FDA to support product registration goals
- Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling)
- Foster transparent communication, feedback, and continuous development
- Represent GRA at stakeholder/governance meetings; mentor GRA personnel
- Build external stakeholder relationships; advise promotional strategy and review press/IR materials
Minimum Qualifications
- Advanced scientific degree (PharmD, PhD) and 8+ years in regulatory affairs and/or drug development
OR
- Bachelor’s or Masters and 10+ years in regulatory affairs and/or drug development
Additional Preferences
- Global regulatory procedures knowledge; experience across US, EU, China, Japan
- Clinical and CMC regulatory science experience
- Leadership, negotiation, and executive-level communication skills
- Risk assessment/management experience; therapeutic area experience
Additional Information
- Travel: 10–15%
Benefits (as stated)
- Eligibility for company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies—from portfolio entry through end of life. You will provide strategic and technical leadership to a cross-functional Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.
Key Responsibilities
- Develop and execute innovative global regulatory strategies, owning 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 GBD/global program team; shape development plans and address regulatory barriers
- Ensure local affiliate regulatory plans align to global strategy and business priorities (labeling, risk management, issues management)
- Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs)
- Drive high-quality communications with FDA articulating scientific position
- Build relationships with FDA to support product registration goals
- Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling)
- Foster transparent communication, feedback, and continuous development
- Represent GRA at stakeholder/governance meetings; mentor GRA personnel
- Build external stakeholder relationships; advise promotional strategy and review press/IR materials
Minimum Qualifications
- Advanced scientific degree (PharmD, PhD) and 8+ years in regulatory affairs and/or drug development
OR
- Bachelor’s or Masters and 10+ years in regulatory affairs and/or drug development
Additional Preferences
- Global regulatory procedures knowledge; experience across US, EU, China, Japan
- Clinical and CMC regulatory science experience
- Leadership, negotiation, and executive-level communication skills
- Risk assessment/management experience; therapeutic area experience
Additional Information
- Travel: 10–15%
Benefits (as stated)
- Eligibility for company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Application Instructions
- If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation