Director, Regulatory CMC Strategy

🔥 20 hours ago

🇺🇸 United States – Remote

💵 $150k - $242k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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 the Regulatory CMC subject matter expert on cross-functional program teams • Align CMC development plans with clinical, regulatory, quality, and business objectives • Provide strategic 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 • 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 • 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

🎯 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, required • Proven 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 • Demonstrated 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

🏖️ Benefits

• 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 • Employee resource groups (ERGs) offering support networks