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Associate Director , Regulatory Strategy Oncology
Directs the development of submission of product/process registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence requirements with regulatory agencies. Interacts and negotiates with regulatory agency in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Participates in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan. Ensures rapid and timely approval and continued approval of products. Serves as regulatory representative to marketing or research project teams and government regul


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