Director/Sr. Director Regulatory CMC, Lilly Regenerative Medicine

At Lilly, we unite caring with discovery to help make life better for people around the world. Headquartered in Indianapolis, Indiana, our 50,000 employees worldwide tackle complex challenges to discover and deliver life‑changing medicines. Join us if you want to bring your best to work that truly matters for patients. Position Director / Senior Director, Regulatory CMC (Gene Therapy Portfolio) Job Responsibilities 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. Minimum Requirements 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.). Additional Preferences 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. Compensation & Benefits 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. EEO & Accessibility Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities in pursuit of positions. If you require accommodation, please complete the accommodation request form at for assistance. Lilly is a proud EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) include Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (View email address on click.appcast.io), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN), and Women’s Initiative for Leading at Lilly (WILL). #J-18808-Ljbffr 100 Eli Lilly and Company