Overview Manages regulatory affairs communication, filing strategy, regulatory negotiation, submission development, query response development and other assigned activities related to the US, EU, Canada and other regions, as required. Provides expertise in translating regulatory requirements into practical, workable plans. Develops and implements strategies for earliest possible approvals of regulatory applications. Provides counsel to and manages a regulatory team. Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments and external representatives (i.e., distributors, agents, regulatory agencies) as needed to support business objectives. Responsibilities Prepare PMAs,
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