I have 4 years of experience in Regulatory affairs pharmaceutical industry.
I possess expertise in dossier preparations (ICH- CTD and ACTD), CMC Compliance, Label review of investigational medicinal products, DMF preparation.
I have good knowledge of ICH guidelines, Variation filing and renewals for EU market and Dossier submission requirements for ROW market.
Has expertise in EU, South Africa and Asia market dossier preparations
Computer skills include MS Project, Excel, MS word, Spreadsheet and PowerPoint.