Senior Scientist, Global Regulatory Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the formulation and execution of the worldwide regulatory strategy for development initiatives.

• Act as the dedicated regulatory subject matter expert for development teams.

• Serve as the primary liaison and lead direct interactions with regulatory authorities.

• Collaborate with R&D to create and execute plans for clinical trial submissions.

• Work alongside internal stakeholders to provide technical guidance on Quality, Safety, and Efficacy sections for regulatory submissions.

• Proactively identify and convey project-specific regulatory risks and opportunities.

⛳️ Requirements

• A Master's degree or higher in veterinary medicine, biology, infectious diseases, immunology, animal science, or a related field.

• A minimum of 10 years of pertinent experience in the animal health sector, including direct regulatory affairs involvement in veterinary pharmaceuticals.

• Proven track record of leading direct submissions and negotiations with regulatory bodies, with a strong preference for experience with the U.S. Food and Drug Administration's Center for Veterinary Medicine (CVM).

• Demonstrated capability to act as the primary regulatory expert on cross-functional project teams within a global context.

• Outstanding communication, negotiation, and influencing skills.

🏝️ 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.