Apply on Employer Site

Elanco · 1 day ago

Senior Scientist, Global Regulatory Project Lead

Washington, DC

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Elanco is a global leader in animal health dedicated to innovation and delivering products and services for farm animals and pets. The Senior Scientist, Global Regulatory Project Lead will define and execute global regulatory strategies for innovation projects, ensuring compliance and alignment with business objectives throughout the product lifecycle.

ManufacturingPetSupply Chain Management

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

Qualification

Regulatory AffairsRisk AssessmentDossier RegistrationVeterinary MedicineContinuous ImprovementInfluencing SkillsFluency in English

Required

Master's degree or higher in veterinary medicine, biologics, infectious diseases, immunology, or a related scientific field

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