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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
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 ...