About company:
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.
Department:
Regulatory affairs
Skills &competencies:
Computer knowledge/eCTD Soft ware knowledge ,good knowledge in ICH &FDA guidelines
Experience required in:
Preparation ,review &Compilation of assigned ANDA/NDA[505b(2)]/projects for filling
Knowledge of eCTD ,Module 2 & 3
Hands on experience in reviewing CMC documents of Solid & Liquid oral dosage forms
Review of Pharmaceutical Development Reports(PDR),Manufacturing & analytical documents
Experience:
2- 4 yrs in us regulatory affairs.
Send resumes to this email:
Hrrcl@aurobindo.com
Work location:
APLRC1- hyderabad, Telangana-500090
