Regulatory Labeling Analyst I

Covetrus

About The Position

Under the direction of the Senior Manager, Trade Compliance, the Regulatory Labeling Analyst supports regulatory compliance activities related to Covetrus North America’s growing portfolio of private brand products, including the development, review, and approval of the company’s private brand product labeling and product registration. This position ensures Covetrus North America’s private brand product labeling is compliant with federal and state regulations (e.g., FDA, DEA, and state laws and regulations). The Regulatory Labeling Analyst I will communicate with both internal and external stakeholders throughout the labeling process for both new label and labeling updates as well as product registration and renewals.

Requirements

Associate's Degree (preferred) or equivalent industry experience and proven track record in job related tasks.
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.
Ability to comprehend basic principles, theories and laws, policies, and procedures that pertain to wholesale drug distribution.
Ability to follow SOPs.
Critical thinking - using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
Ability to pay attention to details.
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.

Nice To Haves

Certified Pharmacy Technician or Certified Veterinary Technician
Proficient in designer software and technologies (such as Adobe InDesign, Illustrator, and Photoshop)
Experience with project management tools (e.g., Asana and Smartsheet)
Experience with Salesforce and/or Quality Management Systems

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.