Senior Scientist, Global Regulatory Lead
About The Position
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: 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.
Requirements
- A 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, with direct regulatory affairs experience in veterinary pharmaceuticals.
- 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).
- 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.
Nice To Haves
- 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).
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.
Benefits
- 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
- 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
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
