.At Elanco (NYSE : ELAN) it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.We're driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and our enterprise.At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success.Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.Making animals' lives better makes life better join our team today!Position Description:Through the application of scientific training, regulatory acumen, and relevant experience, the Regulatory Advisor will have a deep understanding of the overall pharmaceutical development process and be able to foster a molecule from a product concept through the development process to approval and data driven life cycle management (LCM) evolution for Safety and Efficacy (S&E).- Specifically, the Regulatory Advisor will:Take the lead role in developing the global regulatory strategy for a product concept; Critically evaluate bothearly and late phase data in support of product development; Effectively work within a cross-functional team responsible for the creation, establishment, and delivery of an effective development program; Develop and be responsible for the regulatory strategy in support of global product registration, commercialization, and LCM (S&E); Lead discussions with external partners and/or customers to further refine regulatory strategies; Drive submission execution to maintain compliance, meet the reporting requirements for the registration and approval of new animal drug/veterinary medicinal/specified feed additive applications, within optimal timelines and achieving business appropriate labels.Provide regulatory and technical overview of submissions (dossiers/non-CMC technical sections) pertaining to a product's approval.- The Regulatory Advisor will also:Evaluate scientific information for potential molecule/product/platform acquisition; Participate and lead efforts within external organizations (VICH, NOAH, AHI, AVMA, Animal Health Europe, etc.) that support Elanco's business objectives; Act as an internal technical and regulatory resource for existing products in support of business affiliates and government affairs as well as globalization of these existing products.Functions, Duties, Tasks:Comprehension of and contribution to scientific components (existing data and literature) and how it relates to regulatory strategy globally
