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Regulatory Labeling Specialist

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The Labeling Specialist is responsible for leading labeling artwork development/ revisions for products which may include Rx, Generics and Devices & assessing changes in FDA requirements to identify impact to product labels. The manager is also responsible for drug listing and providing labeling for periodic reports as per FDA requirements. As a key team member, contributes to the development of labeling processes and procedures to enhance existing practices.
Provide Regulatory support in the development, revision, review and approval of labeling content for submission to FDA, as well as any post marketing labeling changes.
Review new labeling for accuracy and for other regulatory requirements such as NDC codes, DEA requirements, child-resistant.
Liaise with Regulatory Affairs members and other cross-functional teams to ensure the accuracy of all information included on the label or in the labeling.
Support the review process and coordinate with other Regulatory functions for the submission, approval and notification of new/revised labeling content.
Develop and maintain tools/lists that support the coordination with other functions (eg: Quality, manufacturing) to make certain only agency approved labels are produced for appropriate products.
Monitor changes to Referenced Listed Drug (RLD) products
Support Regulatory leads by creating labeling documents for FDA submissions
Maintain, catalog and retail all labeling materials in accordance with company policies, procedures and technologies
Complete electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents
Other job responsibilities as needed

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