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| Associate Director NJ Open (J#28542) Title: Associate Director Company: Eisai Associate Director/Senior Manager, Drug Regulatory Affairs CMC (ECG-US) Regulatory Affairs Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Position location may be in Ridgefield Park, NJ or Research Triangle Park, NC * Support commercial and corporate marketed products initiatives * Development of CMC dossiers and registration strategies in support of commercial objectives * Assessment of change proposals for marketed products and serve as the US Regulatory * Representative on Commercial Change Control Committee * Liaise and negotiate with FDA Review and Compliance divisions as necessary * Provide Regulatory support during FDA pre-approval inspections Qualifications * B.S. degree in pharmacy, chemistry or a related discipline required, advanced degree (MS, PhD) strongly preferred * 5 or more years of Regulatory CMC experience specifically supporting commercial operations * Experience interacting directly with the FDA * Experience in biologics is highly derirable * Eisai is an Equal Opportunity EmployerDate Posted1/25/2008 More... | |||
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