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Lead the global regulatory strategy for novel farm and companion animal products, focusing on successful submissions to the FDA's CVM and EMA. Act as the primary regulatory expert on cross-functional teams to guide product development and manage agency negotiations.
Requires a Master's degree or higher in veterinary medicine or a related science field and at least 10 years of animal health industry experience. Must have demonstrated expertise in leading direct regulatory submissions and negotiations with agencies like the FDA CVM.
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.
Your Role:
Global Regulatory Project Lead
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 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 U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM). 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.
Guide the design and development of the global regulatory strategy for development projects, with a primary focus on CVM/FDA 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 (e.g., CVM, European Medicines Agency (EMA)), including pre-submission meetings and negotiations.
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.
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 pharmaceuticals.
Regulatory Expertise: Demonstrated experience leading direct submissions and negotiations with regulatory agencies, with a strong preference for the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM).
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.
Direct regulatory experience with both farm animal and companion animal products.
Broad experience with global registration processes, particularly leading first-wave submissions in the European Union and other key markets simultaneously.
Experience navigating novel regulatory pathways for innovative products.
A strong understanding of risk assessment and risk management fundamentals.
Knowledge of Continuous Improvement methodologies (e.g., Six Sigma, Lean).
Travel: 10-25%
Location: This is a US-based role. It can be based at our Global Headquarters in Indianapolis, IN (Hybrid), or be a remote position for the right candidate.
Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Multiple relocation packages
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Elanco currently anticipates that the base salary for this position could range from $118,000 to $197,000 depending partly on the successful candidate's qualifications, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending partly on company and individual performance). Additionally, Elanco offers a comprehensive benefit program to eligible employees that includes a company-matching 401(k); vacation benefits; eligibility for medical, dental, vision, and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation is subject to change and could be higher or lower than the range described above. Elanco reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion, and Elanco's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Elanco employees. Estimated application closing date is (insert date). Applications will be accepted on an ongoing basis.
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
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.
Making life better for animals, makes life better.
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.
Offices: 450 Elanco Circle, Indianapolis, IN 46221, US
