Must have Masters degree in Regulatory Affairs or Pharmaceutical Sciences. Must have minimum 2 years of experience in pharmaceutical regulatory affairs. Must have experience in preparing and reviewing electronic pharmaceutical product dossiers, publishing and filing various types of regulatory submissions DMF ANDA NDA 505 b2 IND including Original, amendments and supplements, and presubmission documentation with USFDA. Must be proficient in applicable Computer and database applications including MS word, MS excel, ADOBE and eCTD submissions software.
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