Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy
Eli Lilly and Company
August 09, 2026
On-site
Indianapolis, IN
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 build and lead the Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the US FDA relationship/interaction strategy.
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 resolve regulatory barriers
- Ensure local affiliate regulatory plans align to global strategy and business priorities (labeling, risk management, issues management)
- Oversee all US FDA submissions and interactions (INDs, NDAs, BLAs)
- Drive high-quality FDA communications; build productive FDA relationships
- Lead a cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling)
- Foster transparent communication, feedback, continuous development; share key information across functions
- Represent GRA at stakeholder/governance meetings; mentor personnel and may manage direct reports
- Build strategic external regulatory relationships; advise promotional strategy and review press/IR materials
Minimum Qualifications:
- Advanced scientific degree (PharmD/PhD) + 8+ years in regulatory affairs and/or drug development
OR
- Bachelor’s or Master’s + 10+ years in regulatory affairs and/or drug development
Additional Preferences:
- Deep knowledge of global regulatory procedures and integrated drug development
- Experience with submissions/interactions across US, EU, China, Japan
- Clinical and CMC regulatory experience; leadership/negotiation/stakeholder communication; risk assessment
- Experience in applicable therapeutic area
- Based in Indianapolis, IN; relocation provided; remote not available
Travel: 10–15%
Application Instructions:
- If you require accommodation to submit a resume, complete 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 build and lead the Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the US FDA relationship/interaction strategy.
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 resolve regulatory barriers
- Ensure local affiliate regulatory plans align to global strategy and business priorities (labeling, risk management, issues management)
- Oversee all US FDA submissions and interactions (INDs, NDAs, BLAs)
- Drive high-quality FDA communications; build productive FDA relationships
- Lead a cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling)
- Foster transparent communication, feedback, continuous development; share key information across functions
- Represent GRA at stakeholder/governance meetings; mentor personnel and may manage direct reports
- Build strategic external regulatory relationships; advise promotional strategy and review press/IR materials
Minimum Qualifications:
- Advanced scientific degree (PharmD/PhD) + 8+ years in regulatory affairs and/or drug development
OR
- Bachelor’s or Master’s + 10+ years in regulatory affairs and/or drug development
Additional Preferences:
- Deep knowledge of global regulatory procedures and integrated drug development
- Experience with submissions/interactions across US, EU, China, Japan
- Clinical and CMC regulatory experience; leadership/negotiation/stakeholder communication; risk assessment
- Experience in applicable therapeutic area
- Based in Indianapolis, IN; relocation provided; remote not available
Travel: 10–15%
Application Instructions:
- If you require accommodation to submit a resume, complete https://careers.lilly.com/us/en/workplace-accommodation.