Binita Singh
Regulatory Affairs Officer @Bliss GVS Pharma Ltd.
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WORK HISTORY
Regulatory Affairs Officer @Bliss GVS Pharma Ltd.
Mumbai, IN
Responding to queries asked by regulatory agencies and MOH. Filling of post approval variations, notifications. lifecycle management, dossier preparation and compilation- ROW Market (CTD/ACTD/ Country specific format). Co-ordinating with clients of different countries. Co-ordinating with cross functional departments and plant.
EDUCATION
Oriental Education Societys College of Pharmacy Sanpada Navi Mumbai
Masters in Pharmacy , Quality Assurance
Late Smt Hanjabai Gahlot Charitable Trusts College of Pharmacy Nerul Navi Mumbai
Bachelor of Pharmacy - BPharm, Medicine
ABOUT BINITA SINGH
M pharm graduate working as Regulatory Affairs Officer at Bliss GVS Pharma Ltd. previously worked at Alkem Laboratories in Drug Regulatory Affairs ( DRA) department as trainee. Dealt with various post approval variations for ROW market. Coordinated with cross functional department and plant for documents. Responded to various queries raised by regulatory agencies and authorities. Dealt with dossier preparation, review and submission. Other than this had done internship at Alkem laboratories in ADL department. Having good knowledge about UV, HPLC instrument and dissolution Apparatus handling. Had performed Assay, RS and Dissolution profile for solid dosage forms. Had done daily calibration of weighing balance.
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