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!

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 interacti.

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