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| Associate Director NJ Open (J#28538) Title: Associate Director Company: Eisai Associate Director, Regulatory Affairs - Sepsis/GI 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 GI and Sepsis group * Provide regulatory guidance for top-level project development/core teams * Responsible for managing complex regulatory submissions and communicating regulatory issues to functional areas and transmitting regulatory concerns from functional areas to Sr. Management * Actively liaise with FDA and regulatory authorities to provide/solicit guidance and support for complex submissions * Research and develop regulatory intelligence concerning competitor products * Staff training/management and self-development: supervise Regulatory Managers and Associates providing guidance, training and development to staff members/teams Qualifications * BS in scientific discipline required (Life Sciences, Chemistry, Toxicology or Pharmacology) required, Advanced degree preferred * 5-8 years pharmaceutical experience, at least 4 of which in the regulatory environment * Experience managing mulitple complex submissions and leading FDA or regulatory agency meetings preferred * Comprehensive knowledge of FDA rules, regulations and guidelines and their application in clinical research and development is essential * Experience in managing relationships and interfacing with regulatory bodies as an articulate communicator with strong negotiation skills a plus * Eisai is an Equal Opportunity EmployerDate Posted9/11/2007 More... | |||
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