Global Regulatory Lead – Neuroscience

Eli Lilly and Company

. Develop and execute innovative global regulatory strategies from Candidate Selection through end of lifecycle .

Posted 10/13/2026full-timeIndianapolis • United StatesSenior💰 $175,500 - $257,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in developing and executing global regulatory strategies, with a strong focus on regulatory submissions and agency interactions. Proven ability to lead cross-functional teams and communicate effectively with stakeholders at all levels.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentRegulatory Submissions ManagementLeadership and Stakeholder CommunicationRisk Assessment and ManagementClinical and CMC Regulatory Sciences

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsDrug DevelopmentFDA SubmissionsINDsNDAsBLAsGlobal Regulatory ProceduresRegulatory IntelligenceTherapeutic Area ExpertiseIntegrated Drug Development Process

Soft Skills

LeadershipNegotiationStakeholder CommunicationMentoringCross-Functional Collaboration

Industry Keywords

Regulatory Strategy DocumentHealth Authority GuidanceRisk ManagementIssues ManagementGlobal Program TeamExternal Regulatory StakeholdersPromotional StrategyPress MaterialsGovernance MeetingsContinuous Development

About the role

Key responsibilities & impact

Develop and execute innovative global regulatory strategies from Candidate Selection through end of lifecycle
Own the Regulatory Strategy Document
Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice into regulatory strategies
Lead regulatory representation on the GBD/global program team
Shape development plans and provide solutions to regulatory barriers
Ensure local affiliate regulatory plans align with global strategy and business priorities across 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
Build and leverage relationships with FDA to support product registration goals
Provide strategic direction to a cross-functional Global Regulatory Team
Foster transparent communication, feedback, and continuous development
Communicate key information to enable execution of global regulatory strategy and cross-functional learning
Represent GRA at stakeholder and governance meetings
Mentor GRA personnel
Build strategic relationships with external regulatory stakeholders
Partner with Regulatory Product Communications and Global Marketing on promotional strategy and press/IR materials

Requirements

What you’ll need

Bachelor’s Degree
8+ 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
Travel expected: 10–15%

Benefits

Comp & perks

Company bonus based partly on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical benefits
Dental benefits
Vision benefits
Prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits
Employee assistance program
Fitness benefits
Employee clubs and activities
Relocation provided
Work authorization or visa support/sponsorship for internal applicants only