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Cencora

Senior Manager, Regulatory Affairs – Animal Health Labeling

Cencora

. Manage labeling activities for animal health pharmaceutical and biological products throughout the product lifecycle .

Posted 9/24/2026full-timeRemote • United StatesSenior💰 $76,200 - $119,460 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in regulatory labeling strategies and compliance for animal health pharmaceutical and biological products, with a strong focus on managing submissions and lifecycle activities. Proven ability to provide regulatory guidance and support to cross-functional teams while ensuring adherence to FDA and USDA requirements.

Highest-signal resume keywords
Regulatory Affairs ExperienceLabeling ComplianceSubmission Preparation for FDA-CVM and USDA-CVBVeeva Vault ExperienceCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory SubmissionsLabeling ManagementArtwork Change ControlLifecycle ManagementRegulatory Documentation
Soft Skills
Strong CommunicationOrganizationStakeholder ManagementIndependent WorkClient-Facing Skills
Tools & Technologies
Veeva VaultESubmitterUSDA NCAH Portal
Industry Keywords
Animal Health ProductsPharmaceuticalsBiologicsVaccinesRegulatory Compliance

Tech Stack

Tools & technologies
Vault

About the role

Key responsibilities & impact
  • Manage labeling activities for animal health pharmaceutical and biological products throughout the product lifecycle
  • Develop and implement regulatory labeling strategies supporting compliance, product maintenance, and commercial objectives
  • Prepare and coordinate labeling submissions to FDA Center for Veterinary Medicine and USDA Center for Veterinary Biologics
  • Support labeling components including container labels, cartons, package inserts/product circulars, administration/use instructions, shipper labels, and applicable promotional labeling
  • Lead labeling and artwork changes from initiation and regulatory assessment through approval, implementation, and archival
  • Review labeling content for regulatory compliance, consistency, and alignment with approved applications
  • Prepare submission summaries, justifications, summaries of changes, annotated labeling, artwork components, and supporting documentation
  • Support electronic submission activities using Veeva Vault, eSubmitter, and the USDA NCAH Portal
  • Serve as a regulatory point of contact for health-authority inquiries, deficiencies, commitments, and approvals
  • Track submission milestones, agency feedback, implementation requirements, and labeling histories
  • Assess proposed labeling changes and determine appropriate regulatory strategies and reporting categories
  • Support lifecycle activities, including safety updates, manufacturing changes, product line extensions, market expansion, and product discontinuation
  • Provide regulatory labeling guidance and technical support to cross-functional teams
  • Monitor emerging regulations and identify opportunities to improve labeling processes and submission efficiency
  • Support additional U.S. regulatory programs and client engagements as business needs evolve
  • Work closely with Regulatory Affairs, Quality, Manufacturing, Marketing, Supply Chain, Pharmacovigilance, and other cross-functional stakeholders

Requirements

What you’ll need
  • Bachelor’s degree in a scientific, regulatory, veterinary, pharmaceutical, or related discipline
  • Significant regulatory affairs experience supporting pharmaceuticals, biologics, vaccines, animal health products, or related regulated products
  • Demonstrated experience with product labeling, regulatory submissions, and lifecycle management
  • Strong knowledge of labeling compliance, artwork change control, and regulatory documentation
  • Ability to work independently, manage competing priorities, and provide confident regulatory guidance
  • Strong written and verbal communication, organization, and stakeholder-management skills
  • Experience working effectively in a client-facing and cross-functional environment
  • Preferred: ten or more years of relevant regulatory affairs experience
  • Preferred: direct experience with animal health pharmaceutical and biological products
  • Preferred: experience preparing submissions for FDA-CVM and USDA-CVB
  • Preferred: experience with Veeva Vault, eSubmitter, and the USDA NCAH Portal
  • Preferred: experience communicating directly with U.S. health authorities
  • Preferred: experience providing technical leadership, training, or mentoring within regulatory teams

Benefits

Comp & perks
  • Medical, dental, and vision care
  • Backup dependent care
  • Adoption assistance
  • Infertility coverage
  • Family building support
  • Behavioral health solutions
  • Paid parental leave
  • Paid caregiver leave
  • Training programs
  • Professional development resources
  • Mentorship programs
  • Employee resource groups
  • Volunteer activities