Senior Manager, Regulatory Affairs - Animal Health Labeling

Cencora seeks a Senior Manager in Regulatory Affairs to lead labeling strategy and submissions for animal health pharmaceutical and biological products. The role manages product lifecycle labeling activities, coordinates FDA and USDA submissions, and serves as a regulatory point of contact for cross-functional teams.

Responsibilities

• Manage labeling activities for animal health products throughout the entire product lifecycle
• Develop and implement regulatory labeling strategies aligned with compliance and commercial objectives
• Prepare and coordinate labeling submissions to FDA Center for Veterinary Medicine and USDA Center for Veterinary Biologics
• Lead labeling and artwork changes from initiation through approval, implementation, and archival
• Serve as regulatory point of contact for health-authority inquiries, deficiencies, and approvals

Requirements

• Bachelor's degree in scientific, regulatory, veterinary, pharmaceutical, or related discipline
• Significant regulatory affairs experience with pharmaceuticals, biologics, vaccines, or animal health products
• Demonstrated expertise in product labeling, regulatory submissions, and lifecycle management
• Strong knowledge of labeling compliance, artwork control, and regulatory documentation
• Ability to work independently and manage multiple priorities with confident regulatory guidance
• Strong written and verbal communication with excellent stakeholder management skills