Sr Scientist - Global Regulatory Project Lead - Farm Animal
Elanco
Summary
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.
Job description
Your Responsibilities
- 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.
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 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.
What will give you a competitive edge (preferred qualifications)
- 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).
Requirements
- Master's degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field
- At least 10 years of relevant experience in the animal health industry
- Direct regulatory affairs experience in veterinary pharmaceuticals
- Demonstrated experience leading direct submissions and negotiations with regulatory agencies
- Proven ability to serve as the primary regulatory expert on cross-functional project teams in a global environment
- Exceptional communication, negotiation, and influencing skills
Benefits
- Relocation packages
- Two weeklong shutdowns
- 8-week parental leave
- Employee Resource Groups
- Annual bonus
- Flexible work arrangements
- Up to 6% 401K matching
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Employee assistance program
- Fitness benefits
Company overview
Elanco Animal Health Incorporated is a global leader in the animal health pharmaceutical industry, dedicated to improving the health and well-being of both pets and farm animals worldwide. Founded in 1954 as a division of Eli Lilly and Company, Elanco became an independent public company in 2018 and has since grown to become the world's second-largest independent animal health company. With approximately 9,000 employees globally, the company operates with a clear purpose: 'making life better for animals, makes life better.' Elanco develops innovative medicines, vaccines, and health solutions that empower veterinarians, farmers, and pet owners to advance animal care. The company maintains a balanced portfolio between pet health and farm animal products, offering over 200 brands that address critical health challenges ranging from companion animal diseases to livestock productivity. Headquartered in Indianapolis, Indiana, Elanco is publicly traded on the New York Stock Exchange (NYSE: ELAN) and continues to drive innovation in animal health through strategic acquisitions and dedicated research and development efforts.