What are the responsibilities and job description for the Regulatory & Labeling Specialist position at PRASCO?
General Purpose of Position:
Support all facets of Regulatory and Labeling. Manages accuracy, compliance, and coordination of labeling to meet government and industry standards.
Primary Duties and Responsibilities (Essential Functions):
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Duties/Responsibilities |
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Provide regulatory assistance with review and approval of all labeling components for various types of products (including, but not limited to OTC, Dietary Supplements, and RX products) |
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Utilize Global Vision Software in Regulatory Review |
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Assists in the review and approval of marketing and promotional materials |
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Regulatory Labeling Project Management of timelines |
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Product Profile Review and Approvals |
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Preparation of materials for FDA submissions |
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Interface with appropriate colleagues in labeling and regulatory to deliver and manage the appropriate processes and systems to assure the timely submission and approval of product labeling |
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File and Data management – Maintaining documentation of control systems and version tracking |
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Correspondence with existing partners |
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Review of drug listings and any FDA submissions |
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Support labeling team |
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Responsible for maintaining compliance with regulatory requirements for labeling |
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Find labeling approvals |
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Assist in Change Controls and Regulatory Impact Assessments |
Work Shift:
This position works days. Onsite in Mason, OH
Knowledge, Skills and Abilities:
- Works well independently on assigned tasks, as well as, to accept direction on given assignments
- Possess exceptional communication skills
- Flexibility
- Strong organizational skills and prioritization
- Detail-oriented
- 21 CFR 201 and FDA Requirements
Education and Experience:
- Bachelor’s degree preferred
- Labeling/QA and pharmaceutical experience preferred
- Experience in utilizing Illustrator and Quark software/MAC System preferred
- Proven ability to utilize Microsoft Office software products with a high level of proficiency
Physical Demands and Work Environment:
- Required to sit, talk, see, and hear. Occasionally required to walk, lift and/or move up to 25 pounds. Must use hands and fingers to operate computer.
- Must have the ability to adjust focus for unplanned activities and other duties as assigned. Daily contact requires courtesy, discretion, and sound judgment.
- The work environment is indoors. The noise level in the work environment is usually moderately quiet.
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture, and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.