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| Associate Director NJ Open (J#28540) Title: Associate Director Company: Eisai Associate Director, Postmarketing Regulatory Affairs (EGC) Regulatory Affairs Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * The incumbent will be responsible for, but not limited to providing regulatory input into strategic marketing initiatives and ESI policies regarding advertising and promotional activities * Reviewing and approval of all advertising and promotional materials for assigned products to insure that they comply with FDA regulations * Developmenting, implementating and the maintaining of regulatory procedures regarding review of advertising and promotional materials for marketed products * Acting as regulatory liaison with co-promote partners regarding promotional review * Acting as DDMAC liaison for assigned marketed products to facilitate FDA review * Overseeing overall regulatory labeling function for marketed products * Supervising of Regulatory Coordinator for Labeling * Coordinating with package engineering group for labeling review and approval * Creating and maintaining all labeling files, including labeling history, current labeling, and change control * Assuring utilization of most current labeling in marketing materials Qualifications * Minimum BS degree or higher in life science * Five years pharmaceutical regulatory experience * At least 2 years experience reviewing advertising and promotional materials for prescription drugs or biologics * 2 to 5 years of US prescription drug labeling experience, including FDA labeling negotiations and Core Data Sheets (as they translate to local labeling) * Knowledge of FDA regulations and guidance documents regarding advertising/ promotion and labeling requirements * Good knowledge of MS Office applications (MS Word, Excel, PowerPoint) * Must be very detail-oriented * Must be able to work in a team environment * Must be able to function under tight timelines * Eisai is an Equal Opportunity EmployerDate Posted12/12/2007 More... | |||
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