Senior Scientist, Global Regulatory Lead

Your Role

Global Regulatory Project Lead

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.

Requirements

• 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.

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).

Additional Information

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.