Senior Scientist, Global Regulatory Project Lead

Role Summary

Senior Scientist, Global Regulatory Project Lead will be accountable for defining and executing global regulatory strategy for innovation projects, with a primary focus on first-wave registrations in key markets. This role partners closely with cross-functional development teams and leads regulatory activities across the product lifecycle, including pre- and post-approval activities in the United States. You will serve as the regulatory voice on development and governance teams, ensuring compliance, risk management, and alignment with business objectives.

Responsibilities

• Lead the design and execution of global regulatory strategies and development of technical regulatory documentation for innovation projects
• Provide regulatory leadership and coaching to ensure timely delivery, compliance, and successful outcomes across programs
• Represent Regulatory Affairs on development teams and governance forums, including regulatory risk and benefit evaluations
• Lead or support regulatory agency interactions related to Quality, Safety, and Effectiveness sections
• Collaborate with regional and local regulatory leaders to ensure efficient and effective Health Authority interactions

Qualifications

• Required: Education: Master’s degree or higher in veterinary medicine, biologics, infectious diseases, immunology, or a related scientific field
• Required: Experience: Minimum of 10 years of experience in the animal health industry with direct Regulatory Affairs responsibility for pharmaceutical, biological, and or nutritional products
• Required: Experience: Demonstrated regulatory leadership and dossier registration experience, including knowledge of global regulatory procedures
• Required: Experience: Strong understanding of risk assessment and risk management principles, with the ability to make decisions in complex or ambiguous situations
• Preferred: Fluency in English, additional languages a plus
• Preferred: Advanced degree in Life Sciences or Management
• Preferred: Knowledge of Continuous Improvement methodologies, including Six Sigma and Lean principles
• Preferred: Experience working with novel regulatory pathways or mechanisms
• Preferred: Demonstrated ability to influence, partner cross-functionally, and diplomatically challenge when needed

Education

• Master’s degree or higher in veterinary medicine, biologics, infectious diseases, immunology, or a related scientific field

Additional Requirements

• Travel: 10–25%
• Location: Washington, DC