Regulatory Labeling Analyst I

SUMMARY Under the direction of the Senior Manager, Trade Compliance, the Regulatory Labeling Analyst supports regulatory compliance activities reputed company to reputed company 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 reputed company 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 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.

QUALIFICATIONS: EDUCATION AND/OR EXPERIENCE

• Associate's Degree (preferred) or equivalent industry experience and proven track record in job reputed company tasks.
• 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

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 reputed company Office tools and various project management tools. 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
• Reading comprehension - ability to understand written sentences and paragraphs in work-reputed company 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 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.

PHYSICAL DEMANDS/WORK ENVIRONMENT The physical demands described here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodation may be made to reputed company individuals with disabilities to reputed company 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.

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
• Certain positions may include eligibility for a short-term incentive plan

Salary may vary depending on factors such as confirmed job-reputed company skills, experience, and location. It is not typical for an individual to be hired at or near the top end of the range for their role. Compensation decisions are dependent upon the facts and circumstances of each case. Sales Positions are eligible for a Variable Incentive. The pay range for this position is as follows: $46,400-$61,800 reputed company is an equal opportunity/affirmative action employer. reputed company qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. Apply tot his job Apply To this Job