[Hiring] Senior Scientist - Global Regulatory Project Lead @Elanco

Role Description

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, 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 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.

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.

Requirements

• 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).

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