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| Associate Director CA Open (J#27461) Title: Associate Director Company: Gilead Sciences Description The Associate Director, Regulatory Affairs, is responsible for providing leadership in four key operational areas of Regulatory Affairs, Labeling: (1) Organization of Company Core Datasheets (CCDS) and organization of product labeling including version control and archive; (2) Planning and coordination of workflows associated with the review of Core Datasheets by the company's Core Labeling Working Group and Core Labeling Review Committee; (4) Establishment of systems and processes to track implementation of revisions to CCDS into country labeling; (4) Coordination with Commercial Manufacturing of activities relating to final printed labeling. - Knowledge: In-depth working knowledge of operational aspects of labeling and industry best practices and standards pertaining to product labeling or ability and competencies to rapidly establish such working knowledge are critical. - Familiarity with content requirements of labeling is important. - The candidate must possess excellent organizational and project management skills and demonstrated leadership skills and ability to interact across multiple functional areas at senior levels and ability to interact with management. More... | |||
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