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| Associate Director NJ Open (J#28395) Title: Associate Director Company: Executive Search Group Associate Director, Regulatory Affairs Summary Our client is a successful, innovative, fast-growing healthcare company that commercializes company-discovered and other product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular, oncologic, and gastrointestinal therapeutic treatments. They are seeking an Associate Director, Regulatory Affairs, to provide regulatory expertise and support for pre-clinical and clinical areas for investigational and marketed products; If you are looking for a highly visible role and an opportunity to be a part of a newly established regulatory team at this location, please take a look Duties - Develops and oversees the strategic implementations of electronic regulatory submissions processes and systems to ensure the timely and accurate submission of pharmaceutical product applications to worldwide regulatory agencies. - Acts as liaison with the FDA for assigned investigational products, interacting with FDA personnel up to and including the Division Director level. - Provides guidance to Project Team on steps necessary to comply with regulatory legislation, regulations, and guidance documents. - Determines regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational products. - Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA to assure compliance with regulatory standards. - Assures that Regulatory Affairs is adequately represented on project teams for assigned products. - Interacts with other Directors/Senior Directors-Regulatory Affairs, CMC-Regulatory, Non-clinical Safety Evaluation, Clinical Development, and Regulatory Submissions to ensure continuity for assigned investigational products. - Oversees and evaluates performance of assigned Managers of Regulatory Affairs. - Researches regulatory information related to assigned projects, including reviewing Web sites and print material, and interfacing with other OPDC RA staff or external consultants. - Reviews documents/reports generated by RA Managers or other project team members to assess the likelihood that the content will meet pre-specified objectives, and provides input towards this end. - Reviews and updates RA processes to ensure the efficient and timely flow of information among the project team. More... | |||
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