Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

About the role

The role of Global Regulatory Lead (GRL) at Lilly involves developing and executing innovative global regulatory strategies from candidate selection through end of lifecycle. The GRL 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 to drive robust, forward-looking strategies
• Lead regulatory representation on the GBD/global program team, shaping development plans and providing solutions to regulatory barriers
• Ensure local affiliate regulatory plans align to global strategy and business priorities — spanning labeling, risk management, and issues management
• Oversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAs
• Drive high-quality communications with FDA that clearly articulate Lilly's scientific position
• Build and leverage productive relationships with FDA to support product registration goals
• Provide strategic direction to a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global Labeling
• Foster a culture of transparent communication, feedback, and continuous development
• Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings
• Represent GRA at stakeholder and governance meetings; mentor GRA personnel

Minimum Qualifications

• Advanced scientific degree (PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug development
• Bachelor’s or Masters and 10+ years of experience in regulatory affairs and/or drug development
• Deep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development process
• Demonstrated experience with regulatory submissions and agency interactions across US, EU, China, and Japan
• Direct experience in both clinical and CMC regulatory sciences
• Strong leadership, negotiation, and stakeholder communication skills — including executive-level audiences
• Proven ability to assess and manage risk in a highly regulated environment
• Experience in the applicable therapeutic area

Additional Preferences

• Experience in the applicable therapeutic area