Regulatory Affairs

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. 

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