Sr Scientist – Global Regulatory Project Lead – Farm Animal

Elanco (NYSE: ELAN) is hiring a Sr Scientist – Global Regulatory Project Lead – Farm Animal to steer regulatory strategy for breakthrough animal health products across the United States. If you thrive at the intersection of veterinary science and agency negotiation, this role puts you at the heart of a global innovation pipeline.

About the Role

As the Global Regulatory Project Lead, you'll work as a senior individual contributor and the go-to regulatory authority on global project teams. From the earliest stages of development, you will shape strategy for novel farm and companion animal products and lead direct discussions with authorities such as the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM). The position calls for someone who can manage intricate agency interactions and align partners across R&D, Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services to secure approvals in the US, EU, and other first-wave markets.

Key Responsibilities

• Shape and execute the global regulatory strategy for development programs, centered on CVM/FDA submissions.
• Act as the dedicated regulatory subject matter expert, offering risk/benefit assessments that inform project direction.
• Serve as the lead contact for engagements with agencies such as CVM and the European Medicines Agency (EMA), including pre-submission meetings and negotiations.
• Work alongside R&D to build and deliver clinical trial submission plans aligned with the broader regulatory approach.
• Provide technical guidance on the Quality, Safety, and Efficacy components of submissions.
• Surface and communicate regulatory risks and opportunities to teams and leadership.
• Uphold all local and global policies, including quality frameworks, the Code of Conduct, and HSE standards.

Qualifications

• Master's degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related discipline.
• A minimum of 10 years in the animal health industry, including hands-on regulatory affairs work in veterinary pharmaceuticals.
• Track record of leading direct submissions and negotiations with regulators, ideally the FDA's CVM.
• Demonstrated success as the primary regulatory expert on cross-functional global teams, with standout communication and influencing skills.
• Preferred: experience across both farm and companion animal products, global first-wave registrations including the EU, novel regulatory pathways, risk management fundamentals, and Continuous Improvement methods such as Six Sigma or Lean.

About Elanco

Driven by the vision of Food and Companionship Enriching Life, Elanco is a global animal health leader committed to preventing and treating disease in farm animals and pets. We champion diversity and fresh thinking as the engines of innovation, offering a collaborative environment where your career can advance. This is a full-time, US-based role with travel of 10–25%.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.