Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Small Molecules

Eli Lilly and Company

Director of Global Regulatory Affairs leading CMC strategies for small molecules at Lilly. Ensuring compliance with global regulatory standards while expediting development and submissions.

Posted 7/28/2026full-timeIndianapolis • 🇺🇸 United StatesLead💰 $148,500 - $257,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Regulatory CMC leadership, with a focus on developing and implementing innovative regulatory strategies for clinical trials and product registrations. Possesses a strong understanding of global CMC regulatory requirements and the ability to provide clear regulatory advice to project teams.

Highest-signal resume keywords

Regulatory CMC LeadershipGlobal CMC Regulatory RequirementsClinical Trials SupportInnovative Regulatory StrategiesSynthetic Molecules Commercialization

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory CMC ExperienceClinical DevelopmentProduct RegistrationRegulatory Strategy DevelopmentTechnical CMC Knowledge

Soft Skills

Clear CommunicationDecision-Making Support

Industry Keywords

Therapeutic ModalitiesManufacturing TechnologiesClinical PhasesSTEM Degree

About the role

Key responsibilities & impact

Provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies
Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations
Development and implementation of innovative regulatory strategies and platform approaches
Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions

Requirements

What you’ll need

B.S. degree in a science, engineering, or a STEM related field (advanced degree preferred)
10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules

Benefits

Comp & perks

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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)