Associate Director, Regulatory Affairs – Biologics

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

As Associate Director, Regulatory Affairs – Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation.

This role guides regulatory activities across development and lifecycle management, partnering closely with R&D, Manufacturing, Quality, Technical Operations, and global regulatory stakeholders.

The ideal candidate brings experience in biologics, vaccines, biotechnology, or pharmaceutical regulatory affairs and has supported regulatory strategy, health authority interactions, and regulatory submissions.

Experience in Animal Health is valued but not required.

This is an opportunity to apply your biologics regulatory expertise to innovative development programs while helping advance products that improve animal health globally.

Your Responsibilities


* Lead regulatory strategy for biologics and vaccine programs across development and lifecycle management activities


* Serve as a primary regulatory contact for interactions with health authorities, including FDA, USDA/CVB, EMA, and other global agencies


* Drive planning, preparation, and submission of regulatory dossiers, agency responses, and supporting documentation


* Provide regulatory guidance on biologics development, manufacturing changes, tech transfer, and lifecycle management


* Partner with R&D, Manufacturing, Quality, Technical Operations, and other stakeholders to align regulatory strategy with program goals

What You Need to Succeed (minimum qualifications)


* Education: Bachelor’s degree in a scientific or technical discipline required


* Experienced product Regulatory Affairs professional with 5+ years of direct RA experience, ideally biologics/vaccines or CMC, who has owned regulatory strategy, submissions and agency interactions and is either Indianapolis-based or clearly willing to relocate.


* Experience supporting regulatory strategy, regulatory submissions, health authority interactions, or agency responses


* Knowledge of biologics development, manufacturing processes, and product lifecycle management


* Ability to work cross...