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Covetrus · 8 hours ago

Regulatory Labeling Analyst I

Greater Cleveland

Full-time

Onsite

New Grad, Entry Level

$46K/yr - $62K/yr

0+ years exp

Covetrus is a company focused on regulatory compliance for animal health products, and they are seeking a Regulatory Labeling Analyst I to support their private brand product labeling activities. The role involves ensuring compliance with federal and state regulations, managing labeling processes, and communicating with stakeholders throughout the labeling cycle.

Health CareSoftwareSupply Chain ManagementVeterinary

Responsibilities

Review and approve product packaging and labeling to ensure it meets Covetrus brand and regulatory standards

Support lifecycle management for prescribing information, patient labeling, and packaging artwork, in accordance with Covetrus SOPs

Maintain awareness and understanding of industry-standard labeling practices as well as FDA, DEA, and state labeling regulations

Develop and maintain a thorough understanding of Covetrus policies and FDA regulations for animal health product labeling

Stay up to date on any changes to labeling regulations and communicate changes to relevant departments

As assigned by the Regulatory Labeling Program Supervisor, attend team and status update meetings in support of product launches, artwork revisions, and other labeling needs, and report findings back to the Regulatory Labeling team

Practice active communication with cross-functional teams to keep others informed of project status

Manage labeling artwork pieces in line with existing change management processes

Perform regular drug listing auditing to ensure the accuracy of Covetrus private brand labels on file with regulatory bodies

Develop and maintain an understanding of different supplier processes and methods for product labeling in order to ensure product labeling is accurate to artwork files and Covetrus standards

Communicate artwork revisions and approvals in a timely manner to keep product launches and updates on schedule

Build sustainable relationships of trust through open and interactive communication with both internal and external customers

Support team members across Quality & Regulatory Affairs with investigations and research related to Covetrus’ private brand product labeling and/or product registration requirements, as assigned

Inspect their own work critically and communicate any errors, issues, and/or concerns to the Regulatory Labeling Program Manager

Assist with collecting and tracking metrics related to labeling

Escalate issues pertaining to Regulatory Labeling, including internal and external customer complaints, to the Regulatory Labeling Program Manager

Perform additional duties as assigned

Qualification

Regulatory complianceLabeling standardsProject management toolsMicrosoft OfficeAdobe InDesignSalesforceResearch skillsCustomer mindedCommunicationCritical thinkingAdaptability

Required

Minimum of 0-2 years of related industry experience with exposure to a regulatory, law enforcement, and/or security environment or combination of equivalent education and experience

Customer/Client minded

Ethical conduct

Research skills

Experience with Microsoft Office tools and various project management tools

Reading comprehension – ability to understand written sentences and paragraphs in work-related documents

Critical thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems

Mathematics - using mathematics to solve problems

Technical - proficient on keyboard and operating a computer terminal with multiple software systems

Communication - ability to communicate both verbally and in written format in a professional manner

Adaptability - the ability to adapt to changing situations and perform under tight timelines

Dependability - exhibit punctuality and low absenteeism

Ability to multitask and prioritize tasks in a fast-paced environment meeting or exceeding SLA and established metrics for the assigned tasks