Regulatory Affairs Specialist Job at Amneal Pharmaceuticals, Piscataway, NJ

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  • Amneal Pharmaceuticals
  • Piscataway, NJ

Job Description

AMNEAL PHARMACEUTICALS Regulatory Affairs Specialist: With minimal supervision assists with the preparation of high-quality regulatory submissions to the Food and Drug Administration (FDA) as required, within company timelines and in accordance with regulatory guidelines and applicable federal laws. This includes, but is not limited, to New Drug Application (NDA), Investigational New Drug Application (IND), Biologics License Applications (BLA), Post-Approval Supplements, Annual Reports (AR), and

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