Regulatory Affairs Executive _ Glomed

• Get product registration plan and assigned task directly from RA Manager.
• Percentage of unpassed/ rejected dossiers.
• Progress of registration dossier (except for delays from relevant departments).
• Refer to the products which have similar dosage form, strength, packing form, package material and shelf-life.
• Refer to reliable documents from official sources to find out clinical, pharmacology, pharmacokinetic characteristics… of active ingredient and product.
• Prepare leaflet with bilingual Vietnamese-English content.
• Prepare new domestic/ export drug registration dossiers according to current technique guideline and regulation.
• Prepare variation/ supplementary domestic/ export registration dossiers as requested.
• Prepare renewal domestic/ export drug registration dossiers periodically.
• Translate documents from Vietnamese into English and opposite way as requested.
• Search and update information about Drug/ Food supplement regulation as well as regulatory affairs.
• Ensure reliable and updated source.
• Follow up, receive information/ feedback from Drug Administration of Vietnam (DAV), Vietnam Food Administration (VFA) – Ministry of Health (MOH) about registration supplementary dossier, Decision of Visa number Issuance as well as approval official letter for changing/supplement.
• Understand information/ request and disseminate fully to relevant departments.
• Supplement as requests of authorities about drug/ food supplement registration fully and on time.
• Update regulation/ decision/ circular/ official letter related to product registration, manufacturing and circulation.
• Full information source, organized scientifically to search easily.
• Participate in preparing/ updating SOPs, forms and other documents related to regulatory affairs.
• Archieve, manage registration dossiers and other dossiers, documents..