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| Associate Manager Regulatory MD Open (J#39957) Title: Associate Manager Regulatory Company: MedImmune Status: Full Time, Employee Job Category: Biotech/R&D/Science Location: Gaithersburg, MD 20878 Location: MD Gaithersburg - Corporate Headquarters Req: 02752 Major Duties and Responsibilities (including supervising others): Responsible for coordinating the development and implementation of new and revised printed labeling for assigned products. Support the labeling content development of CDSs USPIs and other regional labeling for assigned products. 1. Manage the creation approval and implementation timeline of printed labeling for RA-Labeling in collaboration with various functions within Operations for assigned products 2. Perform functions pertaining to US/EU/ROW regulatory submission documentation including coordination review and approval. 3. Ensure proper version control and document integrity of printed labeling 4. Originate precedent searches and assist in analysis of competitive labeling 5. Maintain labeling history documents and assist in responding to labeling-related queries from various functional areas 6. Interact with appropriate functional groups to obtain labeling annotations and supporting documentation 7. More... | |||
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