Senior Scientist, Global Regulatory Project Lead

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 method...