via Workday
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Lead global regulatory strategies and documentation for animal health products, ensuring compliance and effective agency interactions.
Minimum 10 years in animal health regulatory affairs with dossier registration experience and knowledge of global regulatory procedures.
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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. 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! As Senior Scientist, Global Regulatory Project Lead, you will be accountable for defining and executing global regulatory strategy for innovation projects, with a primary focus on first-wave registrations in key markets. This role partners closely with cross-functional development teams and leads regulatory activities across the product lifecycle, including pre- and post-approval activities in the United States. You will serve as the regulatory voice on development and governance teams, ensuring compliance, risk management, and alignment with business objectives. Your Responsibilities Lead the design and execution of global regulatory strategies and development of technical regulatory documentation for innovation projects Provide regulatory leadership and coaching to ensure timely delivery, compliance, and successful outcomes across programs Represent Regulatory Affairs on development teams and governance forums, including regulatory risk and benefit evaluations Lead or support regulatory agency interactions related to Quality, Safety, and Effectiveness sections Collaborate with regional and local regulatory leaders to ensure efficient and effective Health Authority interactions What You Need to Succeed (Minimum Qualifications) Education: Master’s degree or higher in veterinary medicine, biologics, infectious diseases, immunology, or a related scientific field Experience: Minimum of 10 years of experience in the animal health industry with direct Regulatory Affairs responsibility for pharmaceutical, biological, and or nutritional products Demonstrated regulatory leadership and dossier registration experience, including knowledge of global regulatory procedures Strong understanding of risk assessment and risk management principles, with the ability to make decisions in complex or ambiguous situations What Will Give You a Competitive Edge (Preferred Qualifications) Fluency in English, additional languages a plus Advanced degree in Life Sciences or Management Knowledge of Continuous Improvement methodologies, including Six Sigma and Lean principles Experience working with novel regulatory pathways or mechanisms Demonstrated ability to influence, partner cross-functionally, and diplomatically challenge when needed Additional Information Travel: 10–25% Location: Washington, DC Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.
This job posting was last updated on 1/15/2026