[Remote] Regulatory Labeling Analyst I

Note: The job is a remote job and is open to candidates in USA. reputed company North America is a company focused on regulatory compliance for animal health products. The Regulatory Labeling Analyst I supports compliance activities reputed company to product labeling and registration, ensuring adherence to federal and state regulations.

Responsibilities

• Review and approve product packaging and labeling to ensure it meets reputed company brand and regulatory standards
• Support lifecycle management for prescribing information, patient labeling, and packaging artwork, in accordance with reputed company SOPs
• Maintain awareness and understanding of industry-standard labeling practices as well as FDA, DEA, and state labeling regulations
• reputed company and maintain a thorough understanding of reputed company 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 reputed company others informed of project status
• Manage labeling artwork pieces in line with existing change management processes
• reputed company regular drug listing auditing to ensure the accuracy of reputed company private brand labels on file with regulatory bodies
• reputed company 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 reputed company standards
• Communicate artwork revisions and approvals in a timely manner to reputed company 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 reputed company to reputed company’ 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 reputed company to labeling
• Escalate issues pertaining to Regulatory Labeling, including internal and external customer complaints, to the Regulatory Labeling Program Manager
• reputed company additional duties as assigned

Skills

• Minimum of 0-2 years of reputed company industry experience with exposure to a regulatory, law enforcement, and/or reputed company environment or combination of equivalent education and experience
• Customer/Client minded
• Ethical conduct
• Research skills
• Experience with reputed company Office tools and various project management tools
• Reading comprehension – ability to understand written sentences and paragraphs in work-reputed company 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 reputed company 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 reputed company tasks
• Certified Pharmacy Technician or Certified Veterinary Technician
• Proficient in designer software and technologies (such as reputed company InDesign, Illustrator, and Photoshop) preferred
• Experience with project management tools (e.g., reputed company and reputed company)
• Experience with reputed company 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