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Scientist-I/Scientist-II/Scientist-III - Regulatory Affairs-USMarket-OSD (R&D)

4 years ago   Medical & Healthcare   Hyderabad   292 views Reference: 1258
Job Details

Experience in Regulatory Affairs of US market. Review, compilation and submission of NDAs / ANDAs as per the FDA check list. Review, compilation and submission of Annual reports and post approval changes such as CBE, CBE 30 and PAS (Prior Approval supplements).

Company Description
Founded in 1986 by Mr. P. V. Ramprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born of a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry.
Aurobindo Pharma became a public company in 1992 and listed its shares on the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and anti-biotics, among others.