Senior Director - Global Regulatory Affairs - Global Regulatory Lead, Regulatory Strategy

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 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
• Lead 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 and may manage direct reports
• Shape the external regulatory environment by building strategic relationships with key external stakeholders
• Partner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review press/IR materials

Minimum Qualifications

• Advanced scientific degree (i.e. PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug development
• OR 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

• 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

Location

893 S Delaware St
Indianapolis
Indiana
46285
United States