Director of Global Regulatory Affairs, Pharmaceutical Innovation

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.

We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

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!

Your Role: Director of Global Regulatory Affairs, Pharmaceutical Innovation

The Director of Global Regulatory Affairs, Pharmaceutical Innovation will lead global regulatory strategy development, evaluate early and late phase data, and collaborate cross-functionally to create effective development programs for pharmaceutical products.

They will also oversee regulatory strategies for product registration, commercialization, and life cycle management, as well as evaluate scientific information for potential acquisitions and represent the company in external organizations.

Additionally, they will serve as an internal technical and regulatory resource for existing products to support business affiliates and market access efforts.

Your Responsibilities:


* Design and develop creative global regulatory strategy and technical regulatory documents based on interpretation of both regulatory and scientific information


* Possess knowledge of and compliance with relevant laws and regulations, and global policies and procedures


* Lead the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers and maintaining positive relationships with those parties.


* Serve as a resource to development teams and the commercial organization to actively address informational needs, including global and regional promotional material review.


* Lead the delivery of compliant commercial labels during the pre-launch phase across major geographies (EU/US), ensuring timely market access and regulatory compliance.

What You Need to Succeed (minimum qualifications):


* Education: Minimum master’s degree; DVM or PhD highly desired


* Required Experience: A minimum of 5 years of experience in animal health industry (companion animal health preferred)


* Top Skills Needed: Regulatory affairs experience, and understanding of the animal health industry and the animal drug development process

What will give you a competitive edge (preferred qualifications):


* More year...