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| Job Location | Chandigarh |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
B.Sc. / M.Sc. Chemistry 12 - 15 years relevant experience in looking after Regulatory Department of a reputed API manufacturing company. Shall be responsible for Regulatory Affairs function for regulated & Semi regulated markets. Prepare Dossier for various countries as per the guidelines of each country including CTD format. Organizing the required documents for US FDA submission. Respond to queries raised by regulatory authorities. Preparation of drug master files , site master files and dossiers. Review of specifications like RM , FP and Stability for regulatory compliance. Coordination with various departments like R&D , QC , QA & Production etc. ,
Keyskills :
capa ce eu qms riskanalysis continuousimprovementfacilitation apimanufacturing qa qc fp api fda ctd usfda chemistry preparation specifications ContinuousImprovementCulture egulat yaffairs regulat