Opportunity for M.Pharm, M.Sc to work as Manager - ANDA @ Biocon
Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: Manager -ANDA - HC/JC/2005/12
1.Compilation, review and submission of dossiers for regulatory submissions in US, EU and other emerging markets (e.g. ANDA, Abridged MAA, ANDS etc).
2.Compile and review drug development documents.
3.Provide regulatory insight to cross functional project teams (e.g. R&D, QC/QA, Formulation Development, and Marketing/Business Development).
4.Ensure compliance of regulatory documentation.
5.Address potential response to issues raised by regulatory agencies.
6.Identify regulatory requirements for new product and changes to existing products.
7.Determines the scope of information/documentation necessary to file new registration applications and post-approval changes to regulatory agencies.
8.Meet regulatory project deadlines.
1.Proficiency in pharmaceutical and relevent scientific discipline.
2.Knowledge of regulatory requirement in US,EU & other regulated markets. 3.Ability to read and interpret technical reports.
3.Experience of regulatory submissionson solid oral and sterile liquid products. working on solid oral and sterile liquid products.
Experience: 8-10 Years
Education: M.Pharm, M.Sc
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 12th Dec, 2012
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