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| Associate Director NJ Open (J#45113) Title: Associate Director Company: EmTacq LLC Salary: TBD Job Description: Associate Director, Global Regulatory Strategy- Montville, NJ Candidates Must Have: - MS degree with 10 years industry experience in medical research activities, of which 2 - 5 years include global regulatory experience in related therapeutic are. - Must have strong leadership experience. We have a great opportunity for an Associate Director of Global Regulatory Strategy. This position offers a generous compensation plan and an opportunity to work with a global leader in the pharmaceutical industry where you will be actively involved in decision making on all key development questions as a member of the project team. Responsibilities: - Regulatory dossier and approval processes, i.e. preclinical and clinical study and program designs, licensing, etc.). - Achieve assigned regulatory project goals, milestones and labeling, from development through life cycle. - Represent worldwide Regulatory Affairs on assigned Global Project Teams or represents a region in close cooperation with the GRS who is the GPT member. - Ensure submission and approval of clinical trial applications to enable timely start of the clinical trials for the assigned development products. Give Regulatory Advice on Clinical Trial design based on competitor intelligence and guidelines and Agency meeting strategy for evaluation of major clinical trials. More... | |||
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