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The Regulatory Innovative Medicine Dossier Project Manager, a key member of Global Regulatory Affairs, will be responsible to develop and manage detailed regulatory project plans for major global dossiers. The Director that fills this highly visible role will work in a matrixed cross functional project team, interacting with contributors and leadership within the R&D environment to align optimal submission plans with demanding timelines in full compliance with external and internal requirements.This role requires utilization of in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, and the ability to rapidly learn associated Teva systems and planning software. The position requires regulatory knowledge of content requirements of and experience with major applications, including global NCE marketing applications, product line extensions and supplements.
This is primarily an individual contributor role, though it may include managing 1 or more direct reports at a later stage.
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