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).