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regulatory affairs in Allentown

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  1. Project  Physician

    Description The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex development program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team developing a new molecular entity currently being studied for central nervous system applications. Team matrix interactions include project planning, regulatory affairs, ...

  2. Clinical Regulatory Associate

    Nature and Scope The Regulatory Associate provides administrative support to the Clinical Regulatory group. He/She is responsible for the organization and compilation of the regulatory submissions and maintains the regulatory files to ensure that dossiers are easily retrieved for review by the team. He/She works with pharmacovigilance to process and file Pharmacovigilance reports to the FDA in a timely manner.   Responsibilities Organization and retention of controlled documents, tracking ...