Director, Global Regulatory Lifecycle Management, Small Molecule (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!

Your Role: Director, Global CMC Regulatory Affairs – Biocides/Pesticides, Topicals and Collars

As the Director, you will guide a dedicated team responsible for the global regulatory management of our Biocides, Pesticides, Topicals, and Collar products.

You'll be instrumental in developing regulatory strategies, overseeing submission preparation, and ensuring compliance with global regulatory agencies (including FDA, EMA, EPA, and ECHA) for the maintenance and innovation of these specialized animal health categories.
 

Your Responsibilities:


* Guide, manage, and develop a high-performing global CMC group, ensuring effective resource allocation, performance management, and talent development.


* Provide expert CMC Regulatory advice on submission strategy and tactics for innovation and lifecycle submissions, specifically for complex formulations and delivery systems.


* Represent regulatory CMC expertise on global development teams and governance meetings, providing critical insights on regulatory risk/benefit evaluations.


* Partner with global stakeholders across Elanco, including Technical Development, Global Marketing, Manufacturing, and Quality, to motivate departmental strategy and efficiency.


* Manage the timely submission of post-approval CMC documentation and guide interactions with global regulatory authorities (e.g., FDA-CVM, EMA, EPA) on CMC technical sections.
 

What You Need to Succeed (minimum qualifications):


* Education: Bachelor's Degree in a physical, chemical, or life sciences discipline.


* Experience: A minimum of 10 years of pharmaceutical or chemical regulatory experience, with at least 5 years in the preparation and submission of CMC filings for global markets.


* Skills: Demonstrated leadership ability with experience developing teams, and in-depth knowledge of global regulatory CMC requirements.
 

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


* Experience with complex dosage forms such as topicals, medicated collars, or polymer-based delivery systems.


* Experience navigating the interface between vet...