Senior Manager, Regulatory Affairs

Job Summary

Providing regulatory leadership in a remote, full-time capacity, the Senior Manager, Regulatory Affairs will manage labeling activities for U.S. animal health pharmaceutical and biological products, develop regulatory strategies, and coordinate submissions throughout the product lifecycle.

Key responsibilities

• Manage labeling activities and develop regulatory labeling strategies for animal health products
• Prepare and coordinate submissions to the FDA Center for Veterinary Medicine and USDA Center for Veterinary Biologics
• Support cross-functional teams with regulatory guidance and monitor emerging regulations to enhance labeling processes

Required qualifications

• Bachelor's degree in a scientific, regulatory, veterinary, pharmaceutical, or related discipline
• Significant regulatory affairs experience with pharmaceuticals, biologics, or animal health products
• Demonstrated experience with product labeling, regulatory submissions, and lifecycle management
• Strong knowledge of labeling compliance and regulatory documentation
• Ability to work independently and manage competing priorities in a client-facing environment