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Associate Director NJ Open (J#28541)

Title: Associate Director
Company: Eisai

Associate Director/Senior Manager, Regulatory Affairs - CNS (EGC) Regulatory Affairs Eisai Medical Research Inc. -- Ridgefield Park, New Jersey Job Description * Develop, implement and execute regulatory strategic plans and best practice departmental procedures for the therapeutic area group * Provide regulatory guidance for top-level project development/core teams * Actively liaise with FDA and regulatory authorities to provide/solicit guidance and support for complex submissions * Research and develop regulatory intelligence concerning competitor products and disseminate competitive intelligence to project and core teams * Staff training/management and self-development Qualifications * Bachelor's degree in scientific discipline required (Life Sciences, Chemistry, Toxicology or Pharmacology). Doctorate degree highly desired (e.g., MD, JD, Pharm D, or PhD in life sciences) * 3-8 years FDA experience as Project Manager or Clinical Reviewer * Expert understanding of pharmaceutical operations and regulatory compliance requirements together with broad understanding and experience of the clinical development process a plus * Expertise in managing relationships and interfacing with regulatory bodies as an articulate communicator with strong negotiation skills a plus * Eisai is an Equal Opportunity EmployerDate Posted8/27/2007
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