Global Regulatory Lead - Immunology
Eli Lilly and Company
September 01, 2026
On-site
Boston, MA
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; 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 GBD/global program team; shape development plans and solve 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 communications with FDA; build productive FDA relationships
- Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, CMC, Devices, RD&E, Global Labeling)
- Foster transparent communication and continuous development; communicate key information for execution
- Represent GRA at stakeholder/governance meetings; mentor personnel
- Shape external regulatory environment via strategic stakeholder relationships
- Partner with Regulatory Product Communications and Global Marketing on promotional strategy and press/IR materials
Minimum Qualifications
- Advanced scientific degree (PharmD/PhD) and 8+ years in regulatory affairs and/or drug development
OR
- Bachelor’s or Master’s and 10+ years in regulatory affairs and/or drug development
Additional Preferences
- Global regulatory knowledge; reform initiatives; integrated drug development process
- Submissions/agency interactions across US, EU, China, Japan; clinical and CMC regulatory experience
- Leadership, negotiation, and stakeholder communication (executive-level); risk assessment/management
- Experience in applicable therapeutic area
Additional Information
- Travel: 10–15%
- Indianapolis, IN; relocation provided
Benefits
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
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; 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 GBD/global program team; shape development plans and solve 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 communications with FDA; build productive FDA relationships
- Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, CMC, Devices, RD&E, Global Labeling)
- Foster transparent communication and continuous development; communicate key information for execution
- Represent GRA at stakeholder/governance meetings; mentor personnel
- Shape external regulatory environment via strategic stakeholder relationships
- Partner with Regulatory Product Communications and Global Marketing on promotional strategy and press/IR materials
Minimum Qualifications
- Advanced scientific degree (PharmD/PhD) and 8+ years in regulatory affairs and/or drug development
OR
- Bachelor’s or Master’s and 10+ years in regulatory affairs and/or drug development
Additional Preferences
- Global regulatory knowledge; reform initiatives; integrated drug development process
- Submissions/agency interactions across US, EU, China, Japan; clinical and CMC regulatory experience
- Leadership, negotiation, and stakeholder communication (executive-level); risk assessment/management
- Experience in applicable therapeutic area
Additional Information
- Travel: 10–15%
- Indianapolis, IN; relocation provided
Benefits
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.