Associate Regulatory Affairs

Endo International

Digha, West Bengal

This Associate regulatory affairs will be responsible for API regulatory affairs related activities for US market.

1) To review the internal DMF documents during development stage and assist internal R & D to decide the control strategy. Compilation of DMF for US Market.

2) To review the quality data, specifications, standard testing procedures (STP), batch manufacturing records, stability, and packaging material data for the compilation of the DMF's.

3) To review outsourced DMF's/tech pack as per the regulatory expectation. To review the route of synthesis and impurity sections of DMF documents based on the published literature and knowledge. Based on route of synthesis, identifying potential impurity, genotoxic impurities in the API and their probable control strategy

4) Handling change control and Change notifications and decision on post approval change category in line with the regulatory guidance for in-house and outsourced API

5) To prepare and review Deficiency Responses... More Detail

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