Director/Sr. Director, Regulatory CMC

🕒 July 16

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $163.5k - $281.6k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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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 implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions • Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines • Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences, and meetings • Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle • Proactively identify and assess regulatory CMC risks and opportunities, developing mitigation strategies and providing strategic recommendations to senior leadership • Stay current with evolving global regulatory requirements, guidelines, and industry best practices pertaining to gene therapies and advanced therapeutic medicinal products (ATMPs) • Lead and mentor junior regulatory CMC professionals, encouraging a culture of excellence and continuous improvement • Contribute to the development and improvement of internal regulatory CMC processes, standards, and templates • Manage external consultants and contractors as needed to support regulatory CMC activities

🎯 Requirements

• Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required • An advanced degree (MS, Ph.D.) is strongly preferred • 5+ years of expertise in regulatory CMC for gene therapy, cell therapy, or other advanced therapeutic medicinal products (ATMPs) • 5+ years of experience with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA, etc.) • In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (e.g., ICH, FDA, EMA) • Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods • Excellent written and verbal communication skills, with the ability to articulate complex scientific and regulatory concepts clearly and concisely • Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders • Strategic thinker with strong problem-solving and decision-making abilities • Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment • Proficiency in regulatory information management systems and Microsoft Office Suite

🏖️ Benefits

• Eligibility to participate in a company-sponsored 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 • Wellness benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)