Global Regulatory Project Lead (m/f/d)

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!

Global Regulatory Project Lead (m/f/d)

As Global Regulatory Project Lead, you will lead regulatory strategy for global innovation projects across pre-approval and development-driven life cycle management, with direct accountability for the European Union (EU) and United States (USA) regulatory approach and processes.
In this role, you will partner with research and development, sales and marketing, supply chain, manufacturing, quality, finance, legal, and technical services teams to align regulatory plans, manage risk, and support first-wave registrations in key countries.

Your Responsibilities:


* Lead global regulatory strategy, submission planning, and technical dossier development for biologics or other large molecule innovation projects, with direct ownership for EU and USA regulatory activities.


* Drive pre-approval and development-driven life cycle management activities, including clinical trial submission plans and Quality, Safety, and Effectiveness content for regulatory agency interactions.


* Partner with cross-functional teams to assess regulatory impact on product development, target label, registration strategy, timelines, and resource needs.


* Lead engagement with regulatory agencies in the EU or USA and coordinate with regional and local regulatory leaders to support approvals in additional first-wave countries aligned to the global strategy.


* Identify regulatory risks and opportunities, prioritize resources, and help develop policies, Standard Operating Procedures (SOPs), and guidance to support compliance and timely delivery.

What You Need to Succeed (minimum qualifications):


* Master’s degree or higher in veterinary medicine, biologics, infectious diseases, immunology, or a related life sciences field.


* A minimum of 10 years of experience in the animal health industry, including direct Regulatory Affairs experience with biologics or other large molecule products.


* Regulatory leadership and dossier registration experience across pre-approval and life cycle management, including submissions or regulatory agency engagement in the EU and/or USA.
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