Global Regulatory Lead - Immunology

Job ID: R-100933Company: LillyLocation: Indianapolis, Indiana, United States of AmericaJob Type: Full TimeCategory: Research & DevelopmentPosted Date: 2026-09-01At 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. About the RoleAs 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.Key ResponsibilitiesRegulatory StrategyDevelop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycleIntegrate competitive intelligence, health authority guidance, and product-specific regulatory advice to drive robust, forward-looking strategiesLead regulatory representation on the GBD/global program team, shaping development plans and providing solutions to regulatory barriersEnsure local affiliate regulatory plans align to global strategy and business priorities — spanning labeling, risk management, and issues managementUS FDA OversightOversee all US FDA submissions and agency interactions, including INDs, NDAs, and BLAsDrive high-quality communications with FDA that clearly articulate Lilly's scientific positionBuild and leverage productive relationships with FDA to support product registration goalsCross-Functional Team LeadershipProvide strategic direction to a cross-functional Global Regulatory Team inclusive of regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and Global LabelingFoster a culture of transparent communication, feedback, and continuous developmentCommunicate 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 personnelExternal EngagementShape the external regulatory environment by building strategic relationships with key external stakeholdersPartner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review press/IR materialsMinimum QualificationsAdvanced scientific degree (i.e. PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug developmentORBachelor’s or Masters and 10+ years of experience in regulatory affairs and/or drug developmentAdditional PreferencesDeep knowledge of global regulatory procedures, evolving reform initiatives, and the integrated drug development processDemonstrated experience with regulatory submissions and agency interactions across US, EU, China, and JapanDirect experience in both clinical and CMC regulatory sciencesStrong leadership, negotiation, and stakeholder communication skills — including executive-level audiencesProven ability to assess and manage risk in a highly regulated environmentExperience in the applicable therapeutic areaAdditional InformationTravel expected: 10–15%This role is based in Indianapolis, IN or potentially Boston Harborside location (3 days/week in office currently) and relocation is providedLilly 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 us.fitly.work), 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 - $248,600Full-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.#WeAreLillySkillsregulatory strategy developmentregulatory submissionsfda agency interactionscross-functional team leadershiprisk managementlabeling regulationsissues managementcompetitive intelligencehealth authority guidanceproduct-specific regulatory advicestakeholder communicationexternal stakeholder engagementregulatory product communicationspromotional strategypress release reviewregulatory affairsdrug developmentclinical regulatory sciencescmc regulatory sciencesnegotiationexecutive-level communicationtherapeutic area expertiseintegrated drug development process