Job Detail
Regulatory Affairs (25K-35K) (JO-171101-139620)
About this Job
Job Highlight
Ø Opportunity to work with high stability Japanese organization
Ø Opportunity to work with well backed up and fast growing up company
Ø Opportunity to gain wide perspective from working in a small size company
Work outline: Responsibility for relating to Regulatory affairs (RA)
Duties & Responsibilities:
Ø Manage the RA documents related to the shipment clearance.
Ø Manage system of artwork development i.e. technical changes, retailed price change, size of the material changes, bar code changes, name change, logo change and review the text changes etc.
Ø Manage the payment related to RA function e.g. all payments to Thai FDA and vendors .Working with all functions and systems to have the smooth and timely payment.
Ø Preparing and support the preparation of documents of RA function for submission to Thai FDA e.g. promotional materials, variations, new drug application and to related organization / institution.
Ø Support the database management, filing, archiving of documentation.
Ø Do the report according to Thai FDA requirement e.g. annual report and the special report for oncology.
Ø Others as assigned task by Manager
Qualifications:
[Must]
Ø Thai nationality, Male or Female, age 24-30 years
Ø Bachelor’s degree of Pharmacy
Ø 1-3 years’ experience in RA field, especially pharmacy/medical equipment registration
Ø English skill & good communication skill
Languages skills
English: Advanced Conversation Level
Japanese: None
Workplace Area: MRT Phahon Yothin
Working Hour: 8:30 – 17:30 (Mon – Fri)
About the Benefit
Salary: 25,000-35,000 THB
☒Social Insurance
☒Accidental and Health insurance OPD/IPD
☒Provident Fund
☒Monetary assistance
☒Bonus depends on Company’s Profit
About the company
Business Type: Trading
Products: Medical device, Medical equipment, Healthcare products and etc.
