Director​/Sr. Director Regulatory CMC, Lilly Regenerative Medicine

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Director / Senior Director, Regulatory CMC (Gene Therapy Portfolio)

• 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 such as FDA, EMA, and PMDA for assigned gene therapy projects, facilitating interactions, teleconferences, and meetings.
• Provide expert regulatory CMC guidance and support to cross‑functional development teams (R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle.
• Proactively identify and assess regulatory CMC risks and opportunities, develop mitigation strategies, and provide 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, fostering 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 to support regulatory CMC activities.

• Bachelor’s degree in a scientific discipline (Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) – required.
• Advanced degree (MS, Ph.D.) – strongly preferred.
• 5+ years of experience in regulatory CMC for gene therapy, cell therapy, or other ATMPs.
• 5+ years of experience with global regulatory submissions (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 (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 dynamic environment.
• Proficiency in regulatory information management systems and Microsoft Office Suite.

• Salary range: $163,500 – $281,600 (annual).
• Full‑time equivalent employees eligible for a company bonus, depending on company and individual performance.
• Comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision, prescription drug coverage, flexible benefits, life and disability insurance, leave of absence, employee assistance program, fitness benefits, and employee clubs.

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