The Global Regulatory Project Lead at Elanco will be a key contributor in guiding the regulatory strategy for innovative farm and companion animal products. This role involves serving as the regulatory expert on global project teams and leading negotiations with agencies such as the U.S. Food and Drug Administration. The position requires strategic navigation of complex agency interactions and collaboration with various internal stakeholders to ensure successful submissions. The ideal candidate will have a strong background in regulatory affairs within the animal health industry.

• A Master’s degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field.
• At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary pharmaceuticals.
• Demonstrated experience leading direct submissions and negotiations with regulatory agencies, particularly with the U.S. Food and Drug Administration's Center for Veterinary Medicine.
• Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment.

• Guide the design and development of the global regulatory strategy for development projects, focusing on CVM/FDA submissions.
• Serve as the dedicated regulatory subject matter expert on development teams, providing risk/benefit evaluations to guide project strategy.
• Act as the primary point of contact for and lead direct engagements with regulatory agencies, including pre-submission meetings and negotiations.
• Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
• Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
• Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership.
• Comply with all company local and global policies including quality frameworks and health, safety, and environment policies.

• Employees at Elanco are often offered competitive compensation with annual bonus and equity eligibility, retirement plans (including a U.S. 401(k)), and comprehensive health coverage—medical, dental, vision, company-paid life and disability—and even pet insurance. Time-off and flexibility typically include generous PTO, U.S. mid-year and year-end paid shutdown weeks, parental leave, and flexible/remote work options. Employees also benefit from strong development programs (onboarding, course libraries, mentorship, nine ERGs, and tiered leadership programs) that support both professional growth and community involvement.