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Regulatory Affairs Supervisor

4 weeks ago

กรงเทพมหานคร, Thailand RGF Full time

**Job Detail**:

- Regulatory Affairs Supervisor (RAPVQA) (50K-65K) (SDG-85607)
- หัวหน้างานกำกับดูแลกิจการ (RAPVQA)- ・To handle regulatory activities (e.g. eCTD, GMP clearance, Import license renewal, etc.), life cycle management within good time and in compliance with company policies and local regulations.
- ・To handle pharmacovigilance (PV) and quality assurance (QA) activities with stakeholders in compliance with local regulations, global and company policies.
- ・To provide recommendations and information related to regulatory, PV and QA to sales and marketing, affiliates, etc.
- ・To establish effective relationship with Thai FDA and gain their trust and respect
- ・Other tasks as assigned.- Thai nationality, Male, Female, age 27 - 37 years old- Bachelor's degree
- At least 3-year work experience as Regulatory Affairs Officer
- Pharmacist License Holder
- At least basic knowledge of regulations, variation, pharmacovigilance
- Good command in English both in oral and written (TOEIC score 600 up preferred)- Good computer literacy (MS office: word, excel, power point, etc.)
- Drive for results, managing and measuring works, problem solving, customer focus, integrity and trust with positive attitude and active learning
- Able to work under pressure of deadline, and a good team player- Experience as regulatory affairs from original medicine company
- Experiences in pharmacovigilance
- Project management background

Language Skill
- English level : None
- Japanese level : None
- Workplace Area: BTS Ploenchit
- Working Hour: 8:30-17:00(Monday - Friday [SAT: None])
- About the Benefits
- 50,000-65,000THB
- About the company
- Product & Service: Various kind of medicines (ex. cardiovascular, diabetes)
- Business Type: Pharmaceuticals;
- หัวหน้างานกำกับดูแลกิจการ (RAPVQA) (50K-65K) (SDG-85607)- ・เพื่อจัดการกิจกรรมด้านกฎระเบียบ (เช่น eCTD, GMP clearance, การต่ออายุใบอนุญาตนำเข้า ฯลฯ) การจัดการวงจรชีวิตภายในเวลาที่เหมาะสมและสอดคล้องกับนโยบายของบริษัทและข้อบังคับท้องถิ่น
- ・จัดการกิจกรรม pharmacovigilance (PV) และประกันคุณภาพ (QA) กับผู้มีส่วนได้ส่วนเสียตามกฎระเบียบท้องถิ่น นโยบายระดับโลกและของบริษัท
- ・เพื่อให้คำแนะนำและข้อมูลที่เกี่ยวข้องกับกฎระเบียบ PV และ QA แก่ฝ่ายขายและการตลาด บริษัทในเครือ ฯลฯ
- ・เพื่อสร้างความสัมพันธ์ที่มีประสิทธิภาพกับ อย.ไทย และได้รับความไว้วางใจและความเคารพจากพวกเขา
- ・งานอื่นๆ ตามที่ได้รับมอบหมาย- สัญชาติไทย, ชาย, หญิง, อายุ 27 - 37 ปี- ปริญญาตรี
- ประสบการณ์การทำงานอย่างน้อย 3 ปีในตำแหน่งเจ้าหน้าที่กำกับดูแลกิจการ
- ผู้ที่มีใบอนุญาตเภสัชกร
- ความรู้พื้นฐานอย่างน้อยเกี่ยวกับกฎระเบียบ การเปลี่ยนแปลง การเฝ้าระวังด้านเภสัชกรรม
- สามารถใช้ภาษาอังกฤษได้ดีทั้งพูดและเขียน (TOEIC 600 คะแนนขึ้นไปจะพิจารณาเป็นพิเศษ)- สามารถใช้คอมพิวเตอร์ได้ดี (MS office: word, excel, power point, etc.)
- ขับเคลื่อนเพื่อผลลัพธ์, การจัดการและวัดผลงาน, การแก้ปัญหา, การมุ่งเน้นที่ลูกค้า, ความซื่อสัตย์และความไว้วางใจด้วยทัศนคติเชิงบวกและการเรียนรู้อย่างกระตือรือร้น
- สามารถทำงานภายใต้แรงกดดันจากเส้นตายได้ และเป็นทีมที่ดี- มีประสบการ

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