Senior Manager, Regulatory Affairs – Animal Health Labeling

Cencora•Conshohocken, PA

11d•$76,200 - $119,460

About The Position

The Senior Manager, Regulatory Affairs – Animal Health Labeling provides regulatory leadership and hands-on execution for U.S. animal health pharmaceutical and biological products. This client-facing role supports labeling and Regulatory Operations activities throughout the product lifecycle, develops regulatory strategies, prepares and coordinates submissions, and supports compliant implementation and maintenance of approved labeling. The position works 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.

Nice To Haves

Ten or more years of relevant regulatory affairs experience.
Direct experience with animal health pharmaceutical and biological products.
Experience preparing submissions for FDA-CVM and USDA-CVB.
Experience with Veeva Vault, eSubmitter, and the USDA NCAH Portal.
Experience communicating directly with U.S. health authorities.
Experience providing technical leadership, training, or mentoring within regulatory teams.

Responsibilities

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 systems such as 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.