Regulatory Affairs Executive

LP & Associates' client

Ho Chi Minh City

Posted 71 months ago

RESPONSIBILITIES

• 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 shelflife.
  
• 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..

REQUIREMENTS

• Pharmacist Bachelor.
• At least 2 years experience at equivalent position.
• Organizational, job arrangements skills.
• Data analysis and processing skills.
• Writing and presentation skills.
• Proficient computer skill.
• English skill: Enough to search and understand English professional document and preprare English dossier as well as bilingual translation, English communication related to regulatory affairs.

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