Regulatory Affairs Supervisor

6 days ago


กรงเทพมหานคร, Thailand Reeracoen Thailand Full time

**Industry**: Trading(Food), Trading(Other), Trading(Computer/Telecommunication), Trading(Cosmetics/Healthcare), Trading(Machinery), Trading(Automotive), Trading(Electronics/Semiconductors), Manufacturing(Cosmetics/Healthcare), Trading(Pharmaceutical/Medical Equipment), Manufacturing(Pharmaceutical/Medical Equipment)
- ** Job Description**:

- ‐ 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 handle database management.
- 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.
- ** Requirement**:

- 【Must】
- Bachelor degree in Pharmacist with pharmacist license
- At least 3 years work experience as regulatory affairs officer

‐ At least basic knowledge of regulations, variation, pharmacovigilance
- Good command in English both in oral and written (TOEIC score 600 up preferred)

【Advantage】
- Experience in project management background is preferred
- Basic knowledge of regulations, variation, pharmacovigilance
- 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 dead line, and a good team player
- **English Level**: Level 3 - Business Level
- ** Other Language**: English
- ** Working Hour**: 8:30 ~ 17:00
- ** Holiday**:

- Sat, Sun
- Public holidays
- ** Benefit**:

- Pharmacist License: 5,000THB
- Social Security
- Medical Insurance
- Health Check Up
- Company party
- Bonus
- Others



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