Regulatory Affairs intern supporting compilation of Annual Reports and PADERs at Cosette Pharmaceuticals. Engaging with experienced professionals in a collaborative, learning environment.
Responsibilities
Learn content and format of Annual Reports and compile Annual Reports for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs)
Learn content and format of PADERs and compile PADERs for NDAs and ANDAs
Create and review Labels and Patient Information
Learn Electronic Common Technical Document (eCTD) software and compile submissions
Requirements
Experience with MS Word and PDF
Ability to learn new software
Currently pursuing a bachelor’s degree in chemistry, pharmacy, regulatory science or related discipline.
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