Senior Regulatory Affairs Scientist - Animal Health Biologics (CMC, USDA)

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: Senior Regulatory Affairs Scientist - Animal Health Biologics (CMC, USDA) As the Senior Regulatory Affairs Scientist , 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.Your Responsibilities:• 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 innovationWhat You Need to Succeed (minimum qualifications):• 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 teamsWhat Will Give You a Competitive Edge (preferred qualifications):• 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 relationshipsAdditional Information:• Travel: Minimal to moderate, as required• Location: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work EnvironmentElanco 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.