Associate Director, Regulatory Starting Material

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $126k - $268.4k / year

⏰ Full Time

🟠 Senior

🚔 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

• Lead identification, justification, and regulatory strategy for Regulatory Starting Materials across drug substance synthetic routes • Manage starting material resupply campaigns and scale-up efforts, including inventory, production forecasts, manufacturing timing, suite reservations, and contracting • Author and review CMC regulatory submission content for INDs, NDAs, and MAAs • Prepare and lead health authority interactions, including Type C meetings and scientific advice procedures • Partner with Process Chemistry and Analytical Development to evaluate synthetic routes, structural relevance, impurity fate-and-purge, and risk assessments • Define and document the boundary between non-GMP and GMP manufacturing steps • Lead technology transfer and process changes affecting RSM designation toward commercial manufacturing • Manage drug substance/API CMO and RSM supplier relationships, including technical oversight, site visits, supplier qualification, and dual sourcing • Monitor global regulatory guidance and agency precedent and update internal strategy, templates, and risk assessments • Collaborate with Regulatory Affairs, Quality, Supply Chain, and Manufacturing to support timelines, submissions, and supply continuity • Support due diligence activities involving drug substance manufacturing routes and starting material risk • Provide subject matter expertise during regulatory inspections and audits • Build, lead, and mentor a team supporting RSM and drug substance CMC strategy activities

🎯 Requirements

• Advanced degree in chemistry, chemical engineering, or a related field; PhD strongly preferred • 7+ years of relevant experience in CMC, process chemistry, or drug substance/API development and manufacturing • Demonstrated leadership of starting material or CMC regulatory strategy programs • Demonstrated experience supporting late-stage clinical and/or commercial drug substance programs • Deep working knowledge of ICH Q11 and applicable regional guidance/expectations governing Regulatory Starting Material selection and justification • Experience authoring and defending CMC regulatory submission content, including health authority interactions related to starting material or drug substance manufacturing strategy • Strong background in synthetic/process chemistry, route scouting, impurity control strategy, and structural relevance arguments • Experience managing relationships with drug substance/API CMOs and raw material suppliers, including batch record reviews and manufacturing oversight • Working knowledge of cGMP requirements for drug substance manufacturing and the GMP/non-GMP boundary • Experience supporting technology transfer of drug substance processes from clinical to commercial scale preferred • Strong leadership, cross-functional collaboration, and scientific writing/communication skills • Ability to identify and address starting material-related risks affecting regulatory timelines, supply, or program success • Domestic and international travel required, approximately 10–20%

🏖️ 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