Regulatory Affairs Pharmacist

1 week ago


หวยขวาง กรงเทพมหานคร, Thailand บริษัท อินโนเมดิแล็บ จำกัด Full time

Regulatory Affairs Pharmacist (New drug, New generic drug)
รับสมัครด่วน

สถานที่ปฏิบัติงาน : กรุงเทพมหานคร(เขตห้วยขวาง)

สาขาอาชีพหลัก : พัฒนาธุรกิจและพัฒนาองค์กร สาขาอาชีพรอง : พัฒนาธุรกิจ

รูปแบบงาน : งานประจำ

ระดับตำแหน่งงาน : ผู้จัดการฝ่าย

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 - ปริญญาโท
- 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
- เบอร์ผู้ติดต่อ : 0846487956

ข้อมูลการติดต่อบริษัท
- 1300 ห้องเลขที่ 3B1 ชั้นที่ 3 ถนนสุทธิสารวินิจฉัย แขวงห้วยขวาง เขตห้วยขวาง กรุงเทพมหานคร 10310 แขวงห้วยขวาง เขตห้วยขวาง จังหวัดกรุงเทพมหานคร 10310 ประเทศไทย

การเดินทาง

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สุทธิสาร

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