Regulatory & Labeling Specialist

PRASCO • Mason, OH

17h • Onsite

About The Position

Support all facets of Regulatory and Labeling. Manages accuracy, compliance, and coordination of labeling to meet government and industry standards.

Requirements

• 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
• Proven ability to utilize Microsoft Office software products with a high level of proficiency

Nice To Haves

• Labeling/QA and pharmaceutical experience preferred
• Experience in utilizing Illustrator and Quark software/MAC System preferred

Responsibilities

• 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)
• Utilize Global Vision Software in Regulatory Review
• Assists in the review and approval of marketing and promotional materials
• Regulatory Labeling Project Management of timelines
• Product Profile Review and Approvals
• Preparation of materials for FDA submissions
• 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
• File and Data management – Maintaining documentation of control systems and version tracking
• Correspondence with existing partners
• Review of drug listings and any FDA submissions
• Support labeling team
• Responsible for maintaining compliance with regulatory requirements for labeling
• Find labeling approvals
• Assist in Change Controls and Regulatory Impact Assessments

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level