งาน 2 ตำแหน่ง: งาน หางาน งานระเบียบและการอนุมัติผลิตภัณฑ์ทางการแพทย์
Regulatory Affairs (Pharmacist)รหัส:74432
40,000 THB ~ 70,000 THBKing Kaew- Suvarnabhumi , Samutprakarnรายละเอียด
[Product]: Chemical and Medical DeviceResponsibilities:- Preparing registration dossiers according to local regulations and FDA requirements.- Providing support in relation to permits, licenses, approvals and all registrations, including FDA, BOI, OAE and DIW and applying and reviewing the relevant permits/licenses as required by law/regulations.- Managing Thai FDA comments during the submission process and ensuring that products will obtain registration approval within related timelines.- Filing documents for variation amendments.- Ensuring that all key products will be submitted following the strategic plan.- Liaising with the regulatory authorities to obtain registration certificate approval or amendment approval.- Ensuring that products comply with the current laws and regulations.- Providing support in terms of product importation by ensuring that all documents are aligned with local requirements.- Arranging and updating packaging artwork of registered products.
สวัสดิการ
- Travel allowance (actual claim)
- Provident fund
- Social security
- Life & Accident Insurance / Health Insurance
- BonusRegulatory Affairs (Chemical Dept.)รหัส:72396
40,000 THB ~ 60,000 THBBTS (Silom Line), MRT Lineรายละเอียด
[Department] Chemical and General Merchandises Dept- Support the regulatory activities for new submission and renewal submission of Drugs in addition to handling for variation application for change.- Obtain and maintain Thai FDA approvals for all activities and products.- Collaborates and communicates with logistics technicians, customer service representatives, quality personnel, and others involved in the shipment and receipt of products about information related to the shipment.- Tracks, traces, and updates the status of shipments.- Manage cycle counts of product inventories on a regular basis- Prepare all documents for submitting to Thai FDA- Prepare relate material for product sales (sticker, sample board, etc.)- Prepare documents for renew imported and FDA and organization member or license.- Maintain (system) products in warehouse for distribution and prepare shipping documents- Plan & coordinate for counters stock check- Delivery control support- Other task as assigned
สวัสดิการ
- Transportation Allowance (1,500 THB/month)
- Social security
- Provident Fund
- Medical Support
- O.T. Allowance
- Company car with driver (for sales)
- Bonus (Average 4 months)
- Others
