Senior Director, Regulatory Affairs

Overview At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 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 (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. Minimum Requirements Education: 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. Experience: 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.). Additional Preferences 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. Equal Employment Opportunity and Accommodations Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. This is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an 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) offer strong support networks for their members and are open to all employees. Our current groups 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). The anticipated compensation range for this position is $163,500 - $281,600. Full-time equivalent employees are eligible for a company bonus (dependent on company and individual performance) and Lilly offers a comprehensive benefits program, including a company-sponsored 401(k), pension, vacation benefits, medical/dental/vision and prescription drug benefits, flexible benefits, life insurance and death benefits, time off and leave options, and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion. Lilly’s compensation practices and guidelines apply to promotions or transfers within the company. #J-18808-Ljbffr