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!
As the Advisor, CMC Regulatory Affairs – Biologicals, you will provide strategic regulatory guidance to ensure comprehensive, cohesive, and compliant submissions that maintain global product registrations and availability. In this role, you will partner closely with Manufacturing, Quality, R&D, and regulatory authorities to deliver innovative regulatory solutions that support the Elanco pipeline and sustain established biological products.
• Develop and execute regulatory CMC strategies to maintain veterinary biological product registrations and ensure product availability
• Author and review scientifically sound, accurate, and compliant regulatory submissions in collaboration with cross-functional subject matter experts
• Provide regulatory subject matter expertise to QC, QA, and Manufacturing, ensuring inspection readiness and regulatory compliance
• Anticipate and resolve complex regulatory challenges, coordinate and review regulatory commitments, and lead commitment responses
• Drive continuous improvement by building tools, systems, and business processes that enhance regulatory capabilities and foster innovation
• Education: Master’s Degree required
• Experience: Minimum 8 years of experience within a veterinary vaccine or biological manufacturing environment
• Top Skills: Strong regulatory CMC expertise and ability to work independently within cross-functional teams
• Strong understanding of global veterinary biological regulatory requirements (e.g., US FDA, EMA, and other international authorities)
• Demonstrated experience interacting directly with regulatory agencies
• Proven ability to influence cross-functional stakeholders and drive regulatory strategy
• Experience supporting regulatory inspections and post-approval commitments
• Excellent interpersonal and communication skills with the ability to build collaborative relationships
• Travel: Minimal to moderate, as required
• Location: Global Elanco Headquarters – Indianapolis, IN – Hybrid Work Environment
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
At Elanco, we are united by a genuine love and care for animals. Our purpose - making life better for animals, makes life better - fuels us to break boundaries and inspires us to push further, transforming animal care, going beyond to improve outcomes for animals, customers, and society to create a better, more sustainable world. We are veterinarians, pet owners, farmer’s kids and animal lovers. Our team doesn’t just work in the animal health industry - we live it.
By putting customers’ needs at the center of everything we do, our comprehensive portfolios of trusted brands and focused pipeline are transforming the future of animal care. From developing the first treatment for one of the deadliest diseases in puppies to removing needles from diabetes care to pioneering new sustainable market spaces for farmers, we're raising the bar and making a difference - for animals, for our customers and their business.
