Regulatory Affairs Executive

2 weeks ago


sany, India A2Z Jobs Consultancy Full time
JobDescriptions: Prepare and review technical documents and dossiers in the formatof CTD/ACTD. Check thecompliance status of the QualitySystems. Evaluate andcomment on requirements of Clinicalstudies. Prepareartwork of packaging materials as per current rules andregulations. Must haveworked on ASEAN CIS and AFRICAmarkets.
  • Reviewall regulatory agencysubmission materials for accuracy comprehensiveness or compliancewith regulatorystandards
  • Evaluation of changecontrols for postapproval changes(PAC)
  • Compilation review and submission ofVariations
  • Keeping up to date with changes inregulatory legislation andguidelines
  • Description of the product andprocess development
  • Customerqueries to respond andresolve
  • Maintainaccurate and uptodate regulatorydocumentation
  • Coordinate with crossfunctional teams to compilenecessary documentation forsubmissions.

compliance,materials,compilation,legislation,regulations,customer,packaging,pac,asean,documentation


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