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

Eli Lilly and Company • Us, IN

2d • Onsite

About The Position

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 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.

Requirements

• 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

Nice To Haves

• 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

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
• 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

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior