Job Description
Note:
The job is a remote job and is open to candidates in USA. Covetrus North America is a company focused on regulatory compliance for animal health products. The Regulatory Labeling Analyst I supports compliance activities related to product labeling and registration, ensuring adherence to federal and state regulations. 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 Skills 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 bolthires 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 Associate's Degree (preferred) or equivalent industry experience and proven track record in job related tasks Certified Pharmacy Technician or Certified Veterinary Technician Proficient in designer software and technologies (such as Adobe InDesign, Illustrator, and Photoshop) preferred Experience with project management tools (e.g., Asana and Smartsheet) Experience with Salesforce and/or Quality Management Systems Benefits 401k savings & company match Paid time off Paid holidays Maternity leave Parental leave Military leave Other leaves of absence Health, dental, and vision benefits Health savings accounts Flexible spending accounts Life & disability benefits Identity theft protection Pet insurance Certain positions may include eligibility for a short-term incentive plan Company Overview Covetrus specializes in the production and distribution, inventory management, software and prescription management for veterinary care.
It was founded in 2018, and is headquartered in Portland, Maine, USA, with a workforce of 5001-10000 employees. Its website is