Global Regulatory Project Lead - Biologicals

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!
Company Overview

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. We're driven by our vision of 'Food and Companionship Enriching Life' and our approach to sustainability - the Elanco Healthy Purpose™ - to advance the health of animals, people, the planet, and our enterprise.
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: Global Regulatory Project Lead - Biologicals

As the Global Regulatory Project Lead, you will be a key individual contributor at the forefront of our innovation pipeline, guiding the regulatory strategy for novel farm and companion animal biological products. You will serve as the dedicated regulatory expert on global project teams, shaping development from the ground up and leading direct negotiations with agencies like the USDA's Center for Veterinary Biologics (CVB). This role requires a strategic professional who can navigate complex agency interactions, influence cross-functional partners (including Global Research and Development (R&D), Sales and Marketing, Supply Chain, Manufacturing & Quality, Finance, and Technical Services), and ensure our submissions in the United States (US), European Union (EU), and other first-wave countries are successful.
Your Responsibilities

Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVB submissions.
Serve as the dedicated regulatory subject matter expert on development teams, representing the regulatory viewpoint and providing risk/benefit evaluations to guide project strategy.
Act as the primary point of contact for and lead direct engagements with regulatory agencies.
Partner with R&D to develop and implement clinical trial submission plans, ensuring alignment with the overall regulatory strategy.
Collaborate with internal stakeholders to provide technical leadership on Quality, Safety, and Efficacy sections for regulatory submissions.
Proactively identify and communicate project-specific regulatory risks and opportunities to the development team and leadership.
Comply with all company local and global policies including quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety, and environment (HSE) policies.
What You Need to Succeed (minimum qualifications)

Education: A master's degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field
Experience: At least 10 years of relevant experience in the animal health industry, with direct regulatory affairs experience in veterinary biologicals.
Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the USDA - Center of Veterinary Biologics (CVB).
Guidance & Influence: Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment, with exceptional communication, negotiation, and influencing skills.
What will give you a competitive edge (preferred qualifications)

Direct USDA-CVB regulatory experience with both farm animal and companion animal products.
Experience navigating novel regulatory pathways for innovative products.
Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
A strong understanding of risk assessment and risk management fundamentals.
Knowledge of Continuous Improvement methodologies (e.g., Six Sigma, Lean).
Additional Information

Travel: 10-25%
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