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 ImpactArchitect 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 monoclonal antibodies .Agency Exposure: Proven track record of direct, successful interactions and submissions with health authorities (e.g., FDA, EMA, USDA, or equivalent).The Leadership Mindset: Exceptional communication skills with a demonstrated ability to influence matrixed, cross-functional teams without direct authority.Education: Bachelor’s degree in a scientific or technical discipline required (Advanced degree preferred).Preferred Attributes (The Plus, Not the Gatekeeper)Prior exposure to veterinary biologics or animal health regulatory frameworks ( FDA-CVM, USDA-CVB, VICH ).Broad familiarity with CMC principles for biologics (e.g., general understanding of tech transfer or manufacturing changes) to better collaborate with technical operations.Experience navigating multi-regional or truly global product registrations.You May Be a Strong Fit If You:Have led high-level regulatory strategy, not just routine submission execution.Want true ownership of a global portfolio rather than being a small cog in a massive human-pharma machine.Can navigate both long-term strategic planning and detailed regulatory execution.Are excited to apply your complex biologics expertise to an industry focused on improving the health and well-being of animals worldwide.Success in This RoleSuccess means building effective global regulatory strategies, driving high-quality regulatory submissions, influencing strong cross-functional decisions, and helping biologics and vaccine programs advance efficiently through critical development and lifecycle milestones.Compensation / BenefitsCompensation will be aligned to experience, level, and internal equity. This role is eligible for annual bonus opportunities and company benefits.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 sta tus.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.Skill Keywords: Regulatory Affairs • Biologics • Global Regulatory Strategy • Regulatory Submissions • Health Authority Interactions • Biotechnology • Vaccines • Biopharmaceuticals • FDA-CVM • USDA/CVB • EMA • VICH • GMP • Lifecycle Management • Large Molecule Development • Cross-Functional Leadership • Animal Health • Veterinary Biologics • Global Regulatory AffairsElanco 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 statusElanco 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. #J-18808-Ljbffr