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Regulatory Labeling Coordinator

This role is for a REGULATORY LABELING COORDINATOR.

  • The RA Labeling Coordinator is responsible for the preparation of high-quality projects including annual reports, PADERs, and proofreading in accordance to federal regulations and meeting deadlines driven by company's goals. Candidate must possess a strong knowledge of FDA labeling regulations and guidance to the level of applying them effectively to all work output.

Essential Duties & Responsibilities: (1) List the work activities in order of importance (2) Describe and explain each activity in detail (3) Identify the percentage of time spent for each activity Note: the total percentage of time spent for all activities should not exceed 100% Activity % of Time

  • Prepare summary of labeling changes (including components and revision/version information) during a given reporting period for inclusion in a product's Annual Report. In support of the preparation of Annual Reports, deposit PDFs of final printed labeling of all labeling components, for the reporting period being addressed, in the appropriate product file folder of a shared drive. 30%
  • Ensure all proposed Annual Report labeling submissions are ready for scheduled submission by reviewing and approving content for accuracy. 20%
  • Provide product labeling proofreading support, as necessary. 20%

Sthree US is acting as an Employment Business in relation to this vacancy.