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Job Description
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Higher Secondary, Secondary School, Diploma, Advanced/Higher Diploma, Professional Degree, B.Pharma, Post Graduate Diploma, M.Sc
About Central Drugs Standard Control Organisation (CDSCO) FDA Bhawan, New Delhi
Import & Registration Division:
•Scrutinize & examine the Drug Master Files (DMF), Plant Master File (PMF), GMP certificates & COPP etc. from overseas manufacturing units pertaining to Registration & Import License of Drugs, under Form 41, as per the Drugs & Cosmetic Act and Rules.
•Scrutinize the Dossiers to evaluate the adequacy of all technical documents and provides advice on the suitability of registration of overseas manufacturing sites and their products Bulk Drugs (BD) and Finished Formulations (FF) for import into the country as per Drugs and Cosmetics Act & Rules and/or other standard guidelines.
•Experience in Issuance of Import license for import of bulk drugs and finished formulation from the registered site.
•Review the technical files pertaining to the application of Post approval Changes, shelf life extension (for domestic as well as export purpose), Rule-37 (Repacking permissions) etc.
•Prepare queries according to CDSCO guidelines.
•Actively Participate in compilation of draft Guidelines for Registration and Import.
New Drugs Division:
•Scrutinize and examine the technical documents (Dossier) pertaining to investigational New Drug Application (IND), New drug approval (NDA), Subsequent New Drug Approval (SNDA).
•Review forms issued from CDSCO. i.e. Form-10, 28, 45, 45A & 46.
•Review C/T protocol and C/T report.
•Assist in NDAC (New Drug Advisory Committee) Meetings.
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