FRESENIUS KABI USA, LLC – $48,173.00/Year

Bachelors degree or foreign education equivalent in Chemistry, Biology, Pharmaceutical Sciences or Drug Regulatory Affairs plus two 2 years of experience supporting pharmaceutical regulatory affairs within pharmaceutical regulatory affairs or another scientific area. Specific skills other requirements Must also possess the following quantitative experience not applicable to this section 1 Demonstrated expertise DE preparing and filing complete ANDAs, Supplements, Amendments and Annual Reports to the Food and Drug Administration FDA; and 2 DE analyzing the CFR, FDAICH guidelines and cGMPs as they pertain to pharmaceuticals to review technical documents for cGMP and regulatory compliance, and to provide regulatory decisions with regard to acceptability of submission documents and decisions.