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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

 

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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company detail


over 1000 employees


Pharmaceutical


Pharmaceuticals


Full Time


Ho Chi Minh City


English


Executive


English


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


Ms. Nhu Thuyen


Tel: (+8428) 22532930 , Ext : 604


phuong.lan.nguyen@natopjobs.com.vn recruitment@natopjobs.com.vn lanphuong@lp-a.com.vn nhuthuyen@lp-a.com.vn