Global Regulatory Lead - Immunology

Global Regulatory Lead

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 workbut 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.

About the Role

As the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development and execution of global regulatory strategiesfrom 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.

Key Responsibilities

Regulatory Strategy

• 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 prioritiesspanning labeling, risk management, and issues management

US FDA Oversight

• 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

Cross-Functional Team Leadership

• 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

External Engagement

• 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

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 skillsincluding executive-level audiences
• Proven ability to assess and manage risk in a highly regulated environment
• Experience in the applicable therapeutic area

Additional Information

• Travel expected: 1015%
• This role is based in Indianapolis, IN and relocation is provided

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (View email address on click.appcast.io), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

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, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.