Director, Regulatory CMC Strategy
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Job Description
Director leading global Regulatory CMC strategy for Lilly’s small molecule medicines. Driving late-stage submissions, CDMO oversight, and regulatory readiness.
Responsibilities:
- 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 support 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 INDs, CTAs, marketing applications, supplements/variations, briefing packages, and health authority information requests
- Monitor and interpret global regulatory requirements, guidance, and precedent
- Liaise with external development and manufacturing partners, including CDMO 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
- Manage project plans, timelines, budgets, forecasts, and risk mitigation strategies
- Build relationships with internal stakeholders and external partners to advance programs and organizational goals
Requirements:
- Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required; PharmD or PhD preferred
- 8+ 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
- Leadership, project management, communication, and cross-functional collaboration skills
- Experience in orexin, CNS, or other specialty therapeutic areas preferred
Benefits:
- Company bonus based in part on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical benefits
- Dental benefits
- Vision benefits
- Prescription drug benefits
- Healthcare flexible spending accounts
- Dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
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