Global Regulatory Lead - Immunology
Eli Lilly and Company
August 18, 2026
On-site
Indianapolis, IN
Corporate Functions
About The Role
As the Global Regulatory Lead (GRL), you will lead development and execution of global regulatory strategies (from portfolio entry through end of life), provide strategic/technical leadership to the Global Regulatory Team, act as primary regulatory voice on the Global Brand Development team, and own US FDA relationship/interaction strategy.
Key Responsibilities
- Develop and execute global regulatory strategies; own the Regulatory Strategy Document (RSD) from candidate selection through lifecycle end.
- Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice.
- Lead regulatory representation on the GBD/global program team; address regulatory barriers.
- Ensure local affiliate plans align to global strategy (labeling, risk management, issues management).
- Oversee US FDA submissions/interactions (INDs, NDAs, BLAs); communicate Lilly’s scientific position.
- Provide strategic direction to cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling); foster transparent communication; share key learnings.
- Represent GRA at stakeholder/governance meetings; mentor personnel.
- Build relationships with external stakeholders; advise promotional strategy and review press/IR with Global Marketing/Product Communications.
Minimum Qualifications
- Advanced scientific degree (PharmD, PhD) + 8+ years regulatory affairs/drug development; OR Bachelor’s/Master’s + 10+ years.
Additional Preferences
- Global regulatory procedures/reform knowledge; experience across US/EU/China/Japan; clinical and CMC regulatory experience; leadership/negotiation/stakeholder communication (exec audiences); risk management; therapeutic-area experience.
Additional Information
- Travel: 10–15%; based in Indianapolis, IN; relocation provided.
Benefits (as stated)
- Eligibility for company bonus; 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life/death benefits, time off/leave, well-being benefits (EAP/fitness/clubs).
Compensation
- Anticipated base pay: $169,500–$248,600.
As the Global Regulatory Lead (GRL), you will lead development and execution of global regulatory strategies (from portfolio entry through end of life), provide strategic/technical leadership to the Global Regulatory Team, act as primary regulatory voice on the Global Brand Development team, and own US FDA relationship/interaction strategy.
Key Responsibilities
- Develop and execute global regulatory strategies; own the Regulatory Strategy Document (RSD) from candidate selection through lifecycle end.
- Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice.
- Lead regulatory representation on the GBD/global program team; address regulatory barriers.
- Ensure local affiliate plans align to global strategy (labeling, risk management, issues management).
- Oversee US FDA submissions/interactions (INDs, NDAs, BLAs); communicate Lilly’s scientific position.
- Provide strategic direction to cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling); foster transparent communication; share key learnings.
- Represent GRA at stakeholder/governance meetings; mentor personnel.
- Build relationships with external stakeholders; advise promotional strategy and review press/IR with Global Marketing/Product Communications.
Minimum Qualifications
- Advanced scientific degree (PharmD, PhD) + 8+ years regulatory affairs/drug development; OR Bachelor’s/Master’s + 10+ years.
Additional Preferences
- Global regulatory procedures/reform knowledge; experience across US/EU/China/Japan; clinical and CMC regulatory experience; leadership/negotiation/stakeholder communication (exec audiences); risk management; therapeutic-area experience.
Additional Information
- Travel: 10–15%; based in Indianapolis, IN; relocation provided.
Benefits (as stated)
- Eligibility for company bonus; 401(k), pension, vacation, medical/dental/vision/prescription benefits, flexible benefits, life/death benefits, time off/leave, well-being benefits (EAP/fitness/clubs).
Compensation
- Anticipated base pay: $169,500–$248,600.