Regulatory Affairs Lead – Biologics (CMC, Animal Health)

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!

The biologics space in Animal Health is experiencing unprecedented global innovation.

We are seeking a strategic Regulatory Affairs Lead to serve as the primary regulatory architect for our global biologics and vaccine portfolios.

If you are a biologics regulatory professional who feels siloed in human pharma or biotech, this is your opportunity to step into a high-visibility, high-influence role.

You won't just be managing repetitive submission pipelines; you will be partnering directly with executive leadership, R&D, and global health authorities to shape the future of veterinary medicine.

Prior Animal Health experience is highly valued, but absolutely not required—we will fully support your transition if you bring strong biologics depth.

How You Will Make an Impact


* Architect Global Strategy: Design and execute innovative global regulatory pathways for breakthrough biologics, vaccines, and biotechnology programs across their entire lifecycle.


* Lead Health Authority Engagement: Serve as the face of the organization and primary point of contact during strategic negotiations with major global bodies, including the FDA-CVM, USDA-CVB, and EMA.


* Cross-Functional Influence: Act as a critical strategic partner to R&D, Clinical, and Commercial teams, translating complex scientific data into clear, executable regulatory roadmaps.


* Drive Portfolio Advancement: Lead the preparation, authorship strategy, and submission of high-quality dossiers, ensuring robust responses to health authority inquiries to accelerate time-to-market.


* Navigate a Dynamic Lifecycle: Provide high-level regulatory oversight for pipeline expansions, keeping ahead of global regulatory trends and shifting guidance (such as VICH and advanced GMP standards).

What You Bring (Required Experience)


* The Experience: 5+ years of dedicated Regulatory Affairs experience within a regulated life sciences environment (Biologics, Vaccines, Biotechnology, or Pharma).


* The Domain Depth: A strong background supporting global regulatory strategy and submission execution specifically for large molecules, vaccines, or mon...