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

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

• 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

• 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
• This position is based in Indianapolis, IN and relocation is provided, remote is not available for this role.

• Travel expected: 10–15%

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $169,500 - $248,600.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part,…