Regulatory Affairs Director (R7-R8)

Eli Lilly and Company seeks a Regulatory Affairs Director (R7-R8) to support the execution of regulatory projects for gene therapy platforms. Draft and review regulatory applications, supplements, amendments, and variations. Communicate regulatory requirements internally to ensure alignment of regulatory strategy and development activities with global health authority requirements. Serve as regulatory lead for all early and late stage products. Provide product strategy and direction to technical operations, quality, preclinical, clinical, and regulatory teams. #LI-DNI Position requires a Bachelor’s degree in Pharmacy, Chemistry, or a related scientific field followed by 5 years of progressively responsible experience with supporting regulatory affairs for pharmaceutical development projects and marketed products. Experience must include a minimum of: 5 years of experience with preparing Food and Drug Administration regulatory submissions; 5 years of experience with drafting Investigational New Drug applications, Investigational Medicinal Product Dossiers, and New Drug Applications; 5 years of experience with Electronic Common Technical Document elements, structure, and writing; and 5 years of experience with navigating U.S. and international guidelines and regulations for pharmaceutical products. Telecommuting benefit available. Up to 25% domestic and international travel required. #LI-DNI Job location: Indianapolis, IN. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-91519 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285.