Officer / Executive for Regulatory Affairs required in Neuland Labs
Neuland is manufacturer of Active Pharmaceutical Ingredients and provider of Contract Research Services. Neluand has been Preferred Source world wide for APIs and Intermediates for over 25 years. Neluand has 2 manufacturing plants which have been thrice each successfully inspected by USFDA. Their facilities have also been successfully inspected by German Health Authority and EDQM. Neluand has a R&D Centre which houses 130 scientists engaged in NCE custom synthesis work. The custom synthesis is complemented by 2 cGMP Kilo Labs, 1 non-GMP Kilo Lab and cGMP Pilot Plant. Neluand offer custom synthesis and manufacturing services to the Pharmaceutical industry. Neuland latest foray is in Generic peptide synthesis and we are currently offering Building Blocks to the market.
Neuland, a $70 Million company, having the largest market share of Ciprofloxacin Hcl in US & Europe has close to 35 products across 10 different therapeutic segments in its portfolio. Neuland is also a proud recipient of ISO 9001 for Quality, ISO 14001 and ISO 18001 for EHS initiatives and ISO 27001 for Information Security.
Post: Officer / Executive for Regulatory Affairs
Supporting the BMS, technical data packages, preparation of updates of different Active Pharmaceutical Ingredients (API's) for filing purpose to Regulatory Authorities of Various countries as per global regulatory requirements. He would play an active role in supporting ISMS implementation program. Position is in our USFDA inspected facilities at Hyderabad.
M.Sc in Chemistry with 2-4 Years of Post Qualification experience in Regulatory Affairs with Bulk Drug companies. This position reports to the Senior Manager - Regulatory Affairs.
Experience: 2-4 years
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: DRA
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