Senior Director, Regulatory CMC

Eli Lilly and Company

. Develop and execute integrated Regulatory CMC strategies for small molecule programs from preclinical development through late-stage clinical development and regulatory submissions .

Posted 10/25/2026full-timeRemote • United StatesSenior💰 $175,500 - $283,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and executing Regulatory CMC strategies for small molecule programs, ensuring compliance with FDA, EMA, ICH, and cGMP standards while managing cross-functional teams and external partners. Proven ability to lead regulatory submissions and lifecycle management activities, aligning CMC development with clinical and business objectives.

Highest-signal resume keywords

Regulatory CMC Strategy DevelopmentSmall Molecule Drug DevelopmentRegulatory Submissions ManagementCGMP ComplianceProject Management

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Hard Skills

Regulatory CMCIND AuthoringNDA SubmissionsAnalytical DevelopmentManufacturing ProcessesLifecycle ManagementTechnology TransferProcess DevelopmentScale-UpValidation

Soft Skills

LeadershipCommunicationCross-Functional CollaborationProject Management

Certifications & Qualifications

Master's Degree in ChemistryPharmaceutical SciencesPharmDPhD

Industry Keywords

Pharmaceutical IndustryCDMO ManagementHealth Authority InteractionsOrexinCNS Therapeutics

About the role

Key responsibilities & impact

Develop and execute integrated Regulatory CMC strategies for small molecule programs from preclinical development through late-stage clinical development and regulatory submissions
Provide strategic and technical leadership across drug substance, drug product, analytical development, manufacturing, and control activities
Serve as Regulatory CMC subject matter expert on cross-functional program teams
Align CMC development plans with clinical, regulatory, quality, and business objectives
Provide regulatory guidance on development plans, regulatory risk assessment, lifecycle management, and health authority expectations
Lead preparation, review, and approval of CMC content for global regulatory submissions and responses, including INDs, CTAs, marketing applications, supplements/variations, briefing packages, and health authority information requests
Monitor and interpret evolving global regulatory requirements, guidance, and precedent
Manage external development and manufacturing partners, including CDMO selection, oversight, performance management, technology transfer, scale-up, validation, and manufacturing readiness
Ensure compliance with FDA, EMA, ICH, and cGMP expectations while supporting inspection readiness and supply continuity
Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation strategies
Build relationships with internal stakeholders and external partners to support program advancement and organizational goals
Report to the Executive Director, Regulatory CMC

Requirements

What you’ll need

Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required; PharmD or PhD preferred
Minimum of 12 years of pharmaceutical industry experience, including at least 5 years in Regulatory CMC roles supporting small molecule development programs
Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions
Experience authoring, reviewing, and managing CMC regulatory filings, including INDs, IMPDs, NDAs, and global health authority interactions
Strong knowledge of small molecule drug substance and drug product development, analytical development, manufacturing processes, control strategies, and pharmaceutical development principles
Extensive experience managing CDMOs and external development and manufacturing organizations
Thorough understanding of cGMP requirements, ICH guidelines, FDA regulations, and global Regulatory CMC expectations
Experience supporting programs from early development through IND submission and lifecycle management
Experience supporting technology transfer, process development, scale-up, validation, and clinical supply manufacturing activities
Excellent leadership, project management, communication, and cross-functional collaboration skills
Experience in orexin, CNS, or other specialty therapeutic areas preferred
Must be based in the United States

Benefits

Comp & perks

Company bonus depending partly 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
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
Remote work arrangement
Occasional travel