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Regulatory Affairs Executive

cap LP & Associates' client

location Ho Chi Minh City

post time Posted 20 months ago


Position Regulatory Affairs Executive
Function Regulatory Affairs
Location Travel between HCM & Binh Duong
Reporting to Regulatory Affairs Supervisor



  • 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..



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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company detail

over 1000 employees



Full Time

Ho Chi Minh City




144 Phung Van Cung Str, Ward 4, Phu Nhuan Dist, HCMC

Ms. Nhu Thuyen

Tel: (+8428) 22532930 , Ext : 604