Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy
Eli Lilly and Company
June 26, 2026
On-site
Indianapolis, IN
Corporate Functions
About The Role
As the Global Regulatory Lead (GRL), you will develop and execute 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 relationship and interaction strategy with the US FDA.
Key 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 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 US FDA submissions and interactions (INDs, NDAs, BLAs).
- Drive high-quality FDA communications articulating Lilly’s scientific position; build relationships to support registration goals.
- 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 for execution and shared learnings.
- Represent GRA at stakeholder/governance meetings; mentor personnel; may manage direct reports.
- Shape the external regulatory environment via stakeholder relationships.
- Partner with Regulatory Product Communications and Global Marketing on 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 / Skills
- Deep knowledge of global regulatory procedures and integrated drug development.
- Experience with submissions/interactions across US, EU, China, and Japan.
- Experience in clinical and CMC regulatory sciences.
- Strong leadership/negotiation/stakeholder communication (executive-level).
- Risk assessment/management experience in highly regulated environments.
- Experience in applicable therapeutic area.
- Indianapolis, IN based; relocation provided; remote not available.
Additional Information
- Travel expected: 10–15%.
Benefits
- Eligible for company bonus (company/individual performance dependent).
- Company-sponsored 401(k); pension; vacation.
- Medical, dental, vision, prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care FSA); life insurance/death benefits; certain time off and leave; well-being benefits (EAP, fitness benefits, employee clubs/activities).
As the Global Regulatory Lead (GRL), you will develop and execute 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 relationship and interaction strategy with the US FDA.
Key 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 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 US FDA submissions and interactions (INDs, NDAs, BLAs).
- Drive high-quality FDA communications articulating Lilly’s scientific position; build relationships to support registration goals.
- 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 for execution and shared learnings.
- Represent GRA at stakeholder/governance meetings; mentor personnel; may manage direct reports.
- Shape the external regulatory environment via stakeholder relationships.
- Partner with Regulatory Product Communications and Global Marketing on 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 / Skills
- Deep knowledge of global regulatory procedures and integrated drug development.
- Experience with submissions/interactions across US, EU, China, and Japan.
- Experience in clinical and CMC regulatory sciences.
- Strong leadership/negotiation/stakeholder communication (executive-level).
- Risk assessment/management experience in highly regulated environments.
- Experience in applicable therapeutic area.
- Indianapolis, IN based; relocation provided; remote not available.
Additional Information
- Travel expected: 10–15%.
Benefits
- Eligible for company bonus (company/individual performance dependent).
- Company-sponsored 401(k); pension; vacation.
- Medical, dental, vision, prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care FSA); life insurance/death benefits; certain time off and leave; well-being benefits (EAP, fitness benefits, employee clubs/activities).