Yogesh Chede

Background

About Yogesh Chede

Experience in Regulatory Affairs with a master degree (M.Pharm- Quality Assurance) and 2 +Yearsexperience in navigating regulatory approvals procedure. Detail- oriented, highly organized and able toprioritize and organize project to meet deadlines. Strong verbal, written and inter personal communication skill with problem solving abilities proactive and action oriented- Market: ASEAN, Latam, CIS, GCC-Co-ordination with internal departments like BD, ADL, PDL, QA, QC for technical documents required for preparation of DMF-Preparation and Review of Pellets DMF & Dossier as per CTD format for various health authorities like NMRA, ANVISA, INVIMA, NAPP, DAV, PPB, MOH of Iran, NAFDAC, EFAMHCA, NPRA, MOH of Egypt, COFEPRIS etc-Review technical documents like Stability Studies, BMR, Analytical Method Validation, Product Development Report, Process Validation Report, Stability Protocol, Risk Assessment Report-Review of internal documents like COPP, product permission etc. for compliance wrt to the regulatory submission.