Global Regulatory Lead – Neuroscience

Eli Lilly and Company

. Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document from Candidate Selection through end of lifecycle .

Posted 10/12/2026full-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 build strategic relationships with stakeholders to support product registration goals.

Highest-signal resume keywords

Regulatory AffairsRegulatory SubmissionsFDA InteractionsLeadership SkillsRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Global Regulatory ProceduresDrug Development ProcessINDsNDAsBLAsClinical Regulatory SciencesCMC Regulatory SciencesRegulatory Strategy DocumentCompetitive IntelligenceHealth Authority Guidance

Soft Skills

Negotiation SkillsStakeholder CommunicationMentoringTransparent CommunicationFeedback Management

Industry Keywords

Therapeutic AreaRegulatory StrategyCross-Functional TeamProduct RegistrationGovernance Meetings

About the role

Key responsibilities & impact

Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document 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 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 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
Foster 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
Build strategic relationships with key external stakeholders
Partner with Regulatory Product Communications and Global Marketing to advise on promotional strategy and review 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

Benefits

Comp & perks

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, including 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, including employee assistance program, fitness benefits, and employee clubs and activities
Relocation is provided
Travel expected: 10–15%