Our Client, a Japanese Pharmaceutical Company is now seeking for Regulatory Affairs Officer position.
- 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
Personal data collected will be used for employment-related purposes only.
We regret to inform that only shortlisted candidates will be notified.