Regulatory Affairs Pharmacist
6 months ago
Regulatory Affairs Pharmacist (New drug, New generic drug)
รับสมัครด่วน
สถานที่ปฏิบัติงาน : กรุงเทพมหานคร(เขตห้วยขวาง)
สาขาอาชีพหลัก : พัฒนาธุรกิจและพัฒนาองค์กร สาขาอาชีพรอง : พัฒนาธุรกิจ
รูปแบบงาน : งานประจำ
ระดับตำแหน่งงาน : เจ้าหน้าที่
จำนวนที่รับ : 2 ตำแหน่ง
เงินเดือน(บาท) : 60,000 - 80,000
วันทำงาน : จันทร์-ศุกร์
วันหยุด : วันเสาร์, วันอาทิตย์
เวลาทำงาน : 09:00 - 18:00
เวลาทำงานอื่นๆ : ไม่ระบุ
หน้าที่ความรับผิดชอบ
- Prepare and submitting of ACTD dossier for new drug, new generic drug. Support oversea partners to acquire and prepare ACTD.
- Prepare and submitting of CSDT for complicated medical device. Support oversea partner for documents preparation.
- Prepare a report of product registration status, problem, suggest solution and action plan to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. - Provide regulatory guidance to related departments, project developing teams regarding design, development and marketing of products.
- Supported related department to prepare label, package insert, patient insert leaflet, promotional material.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Prepare risk management plan, implement and follow up Pharmacovigilance.
- Develop local RA staff, document system and maintain standard operating procedures.
คุณสมบัติ
- เพศ : ไม่ระบุ
- อายุ(ปี) : 28 - 50
- ระดับการศึกษา : ปริญญาตรี ขึ้นไป
- ประสบการณ์(ปี) : 3ปีขึ้นไป
คุณสมบัติด้านความรู้และความสามารถ
- Male/female 28-50years
- Bachelor’s degree in Pharmacy
- Good English communication skill
- 2-3years experience in pharmaceutical business is a must
- Direct experience in developing of new drug or new generic drug is advantage
- Able to communicate in English for oversea project developing
สวัสดิการ
- ทำงานสัปดาห์ละ 5 วัน
- มีเวลาการทำงานที่ยืดหยุ่น
- ประกันชีวิต
- ประกันสังคม
- ตามข้อตกลงของบริษัท
สนใจสมัครงานตำแหน่งงานนี้กรุณาติดต่อ
- ชื่อผู้ติดต่อ : Varatcholkorn (Oh)
- เบอร์ผู้ติดต่อ : 02 693 1056
ข้อมูลการติดต่อบริษัท
- 1300 ห้องเลขที่ 3B1 ชั้นที่ 3 ถนนสุทธิสารวินิจฉัย แขวงห้วยขวาง เขตห้วยขวาง กรุงเทพมหานคร 10310 แขวงห้วยขวาง เขตห้วยขวาง จังหวัดกรุงเทพมหานคร 10310 ประเทศไทย
การเดินทาง
ไม่มี
ไม่มี
สุทธิสาร
ไม่มี
ไม่มี
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