Regulatory Labeling Analyst I

SUMMARY

Under the direction of the Regulatory Labeling Program Supervisor, 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• 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 Supervisor.
• 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 Supervisor.
• Perform additional duties as assigned.

QUALIFICATIONS:

EDUCATION AND/OR EXPERIENCE

• Assoicate's Degree (preferred) or equivalent industry experience and proven track record in job related tasks.
• Minimum of 0-1 years of related industry experience with exposure to a regulatory, law enforcement, and/or security environment or combination of equivalent education and experience

CERTIFICATES, LICENSES, REGISTRATIONS (Preferred not required)

• Certified Pharmacy Technician or Certified Veterinary Technician

COMPETENCIES (SKILLS AND ABILITIES)

• Customer/Client minded.
• Ethical conduct.
• Research skills.
• Experience with Microsoft Office tools and various project management tools Must be 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
• 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.

PHYSICAL DEMANDS/WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

• Pet-friendly environment
• Extensive computer work
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all responsibilities, duties, knowledge, skills, and abilities required of individuals so classified. Reasonable accommodation may be made to enable individuals with disabilities to perform their duties and responsibilities. Covetrus reserves the right to change job descriptions as business need dictates.

Salary may vary depending on factors such as confirmed job-related skills, experience, and location.

However, the pay range for this position is as follows.

We offer the following benefits for you to take advantage of while you are here provided you meet the eligibility requirements under each governing program:

* 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

* Sales Positions are eligible for a Variable Incentive

* Certain positions may include eligibility for a short term incentive plan

Covetrus is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.