Regulatory Affairs Officer

Job title: Regulatory Affairs Officer
Contract type: Permanent
Location: Hong Kong
Reference: HK_JPC_000636[688]
Contact details: AKIHISA WATANABE
Contact email:
Job published: 6 months ago


Our Client, a Japanese Pharmaceutical Company is now seeking for Regulatory Affairs Officer position.



Kowloon side


  • New Drug Registration and Change of Registered Particulars submission
  • Renewal of Product Registration Certificate
  • Maintenance of Wholesale Dealer License
  • Create and keep Standard Operating Procedures
  • Quality Assurance for own products in Hong Kong
  • Keep Quality Assurance records - Communicate with Department of Health and Relevant parties
  • Maintain and update Product registration folder, Tracking of submission and approval
  • Manage all procedure for Pharmacovigilance and keep PV Training records
  • Manage Product Importation from abroad - Manage Shipment and prepare PO, PI and other documents relating to shipment
  • Customers Service Enquiry (Direct reply to customers)
  • Product enquiry to deal with distributor
  • Confirm statements on materials of promotion an advertising and other documents relating to sales activities


  • Native Cantonese, Fluent in English and Chinese , Japanese is advantage
  • (Min 3 years) Experience in Regulatory affairs


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We regret to inform that only shortlisted candidates will be notified.