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: Regulatory Affairs Lead – Biologics (CMC, Animal Health)

We are seeking a Regulatory Affairs Lead – Biologics (CMC, Animal Health) to lead global regulatory strategy for biologics programs within Animal Health. This role is responsible for defining and driving regulatory strategy, leading health authority interactions, and ensuring successful regulatory submissions across the product lifecycle.

The ideal candidate brings deep experience in regulatory affairs, biologics development, and CMC strategy, with a strong understanding of animal health, veterinary biologics, and global regulatory requirements. This is a high-impact role partnering across R& D, Technical Operations, Manufacturing and Quality to deliver compliant, effective regulatory outcomes.

Your Responsibilities:

• Lead and own global regulatory strategy for biologics programs in Animal Health for CMC development and lifecycle management
• Serve as the primary regulatory lead for health authority interactions regarding CMC, including FDA, USDA/CVB, EMA, and other global agencies
• Drive preparation and delivery of regulatory submissions, ensuring alignment with global regulatory requirements and timelines
• Provide strategic regulatory guidance on CMC development, process changes, comparability, and tech transfer
• Partner cross-functionally with R& D, Technical Operations, Manufacturing, and Quality to align on regulatory strategy and execution
• Lead regulatory risk assessments and develop mitigation strategies to support program success
• Ensure compliance with global regulatory standards, including VICH guidelines and applicable biologics regulations
• Support regulatory strategy for post-approval changes, lifecycle management, and product maintenance

What You Need to Succeed (minimum qualifications):

• Education: Bachelor’s degree in a scientific discipline (advanced degree preferred)
• Experience: Significant experience in Regulatory Affairs within biologics or pharmaceutical development
• Demonstrated experience leading regulatory strategy and submissions
• Experience with health authority interactions and regulatory agency engagement
• Strong knowledge of CMC development and biologics manufacturing processes

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

• Experience in Animal Health or Veterinary Biologics
• Knowledge of VICH guidelines and USDA/CVB regulatory requirements
• Proven ability to lead global regulatory strategy across multiple programs
• Experience supporting process development, comparability, and manufacturing changes
• Strong cross-functional leadership and stakeholder management skills

Additional Information:

This role offers the opportunity to lead regulatory strategy for innovative biologics programs within Animal Health. The position requires strong collaboration across global teams and the ability to influence regulatory outcomes through strategic leadership and expertise.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.