Senior Regulatory Lead - Animal Health Labeling

Cencora; Indianapolis (IN); On-site; USD 76,000 - 119,000; Full time

Job summary

Cencora seeks a Senior Manager, Regulatory Affairs – Animal Health Labeling to lead regulatory labeling for animal health products in the U.S. You will develop strategies, prepare submissions, and coordinate labeling throughout product lifecycles, collaborating with Regulatory Affairs, Quality, Manufacturing, Marketing, and Supply Chain.

This client-facing role drives labeling compliance and lifecycle management.

Qualifications

• Bachelor’s degree in a scientific, regulatory, veterinary, pharmaceutical, or related discipline is required.
• Significant regulatory affairs experience with pharmaceuticals, biologics, vaccines, animal health products, or related regulated products.
• Experience with product labeling, regulatory submissions, and lifecycle management.
• Strong knowledge of labeling compliance, artwork changes, and regulatory documentation.
• Ability to work independently, manage competing priorities, and provide regulatory guidance.
• Strong written and verbal communication, organization, and stakeholder management skills.
• Experience in a client-facing and cross-functional environment.

Responsibilities

• Manage labeling activities for animal health products throughout the product lifecycle.
• Develop and implement regulatory labeling strategies to support compliance and commercial goals.
• Prepare and coordinate labeling submissions to FDA CVM and USDA CVB.
• Support labeling components such as container labels, cartons, inserts, and promotional labeling.
• Lead labeling and artwork changes from initiation through approval and archival.
• Review labeling content for regulatory compliance and alignment with approvals.
• Prepare submission summaries, justifications, and supporting documentation.
• Support electronic submissions using Veeva Vault, eSubmitter, and USDA portals.
• Serve as regulatory point of contact for health-authority inquiries and approvals.
• Track submission milestones, agency feedback, and labeling histories.
• Assess labeling changes and determine regulatory strategies and reporting categories.
• Support lifecycle activities including safety updates and product line extensions.
• Provide regulatory labeling guidance to cross-functional teams.
• Monitor evolving regulations to improve labeling processes and submission efficiency.
• Support other U.S. regulatory programs as needed.

Skills

Regulatory affairs

Labeling

Regulatory submissions

Lifecycle management

Cross-functional collaboration

Client-facing

Regulatory guidance

Education

Bachelor’s degree in a scientific, regulatory, veterinary, pharmaceutical, or related discipline

Tools

Veeva Vault

eSubmitter

USDA NCAH Portal

Job description

Cencora seeks a Senior Manager, Regulatory Affairs – Animal Health Labeling to lead regulatory labeling for animal health products in the U.S. You will develop strategies, prepare submissions, and coordinate labeling throughout product lifecycles, collaborating with Regulatory Affairs, Quality, Manufacturing, Marketing, and Supply Chain.

This client-facing role drives labeling compliance and lifecycle management.