Medicef Pharma
Dra Executive at Medicef Pharma in Baddi
Entry LevelOn-siteFull-timeBaddi
Skills
Drug Regulatory AffairsDRARegulatoryDrugRegulatory affairs
Job Description
Preparation (CTD/eCTD)
Coordination (CDSCO, USFDA, EMA, WHO)
Review and Compilation of (DMF, ANDA)
Handling Regulatory Queries and Variations
Maintenance and Compliance
Support for Audits and Inspections
Liaise with Cross-Functional TeamsPrepare and submit CTD/eCTD dossiers for domestic and global markets
Coordinate with regulatory authorities (CDSCO, USFDA, EMA, WHO)
Compile and review technical documents (DMF, ANDA, MAA)Canteen,Health insurance,Transport facility