Senior Manager, Regulatory Affairs – Animal Health Labeling

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $76.2k - $119.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• 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

• 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

• 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