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

Eli Lilly and Company

Director of Global Regulatory Affairs at Lilly supporting small molecule CMC development and regulatory strategy. Ensuring compliance with global regulations for clinical trials and product submissions.

Posted 4/26/2026full-timeRemote • 🇺🇸 United StatesLead💰 $148,500 - $257,400 per yearWebsite

About the role

Key responsibilities & impact

Provide strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio.
Support clinical trial applications, market registrations, and post approval submissions.
Knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes.
Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment.
Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
Lead preparation, critical review, and approval of CMC documents for global regulatory submissions and responses.
Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.
Provide high quality, timely and clear regulatory advice to project teams.

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.
Experience authoring CMC submission content and involvement in clinical trial applications/marketing authorization application processes including response to questions.
Knowledge of major market procedures, regulations, and practices.
Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
Demonstrated deep knowledge of the synthetic molecule drug development process.
Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
Experience planning for and participating in Health Authority meetings.
Demonstrated ability to assess and manage risk in a highly regulated environment.
Demonstrated strong written, spoken and presentation communication skills.
Demonstrated leadership behaviors and negotiation and influence skills.
Demonstrated attention to detail.
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Benefits

Comp & perks

Eligibility for a company bonus (depending on company and individual performance)
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)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory CMCCMC developmentsynthetic moleculesclinical trial applicationsmarket registrationsregulatory submission strategiesdrug substance developmentdrug product developmentrisk assessmentregulatory guidelines

Soft Skills

leadershipcommunication skillsnegotiation skillsinfluence skillsattention to detailteamworkadaptabilitystrategic thinkingtactical planningoperational leadership

Certifications

B.S. degreeadvanced degree (preferred)