Regulatory Submissions Specialist in , for Idorsia Pharmaceuticals

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Regulatory Submissions Specialist

The Regulatory Submissions Specialist will be responsible for the compilation and submission of Food & Drug Administration (FDA) submissions such as IND, NDA/sNDA and subsequent maintenance activities in eCTD format using appropriate tools and systems. This position will report to a direct line manager located at Idorsia’s headquarters in Switzerland, however, day to day responsibilities and interactions will focus on the US-based Drug Regulatory Affairs (DRA) team, its Operations and Project Leaders. This role requires a great deal of collaboration, deadline management, accuracy & detail. Responsibilities include, but are not limited to: Compilation and submission of FDA submissions, including IND, NDA/sN

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