Executive/AM-Regulatory Affairs -US market

About Client:



It is one of India’s largest pharmaceutical companies.It specializes in generic drugs, active pharmaceutical ingredients (APIs), and biosimilars, and is among the top generic drug suppliers in the U.S. and Europe.



Position - Regulatory Affairs (US market)



Key Responsibilities:

 

•  Hands on experience with RA-US market


•  Responsible for Life Cycle Management of Approved and Tentative Approved ANDAs/NDAs [i.e., filing of supplements (CBE, CBE-30, PAS, Response to Queries, Controlled Correspondence, Annual Reports/Updates etc.]


•  Review and submission of Annual Reports/Updates (for ANDAs/NDAs, PEPFAR applications).


• Good interpretation ...