Regulatory Affair Assistant/เจ้าหน้าที่เภสัชกรขึ้นทะเบียนยา

Regulatory Affair Assistant (30K-42K) (SDG-50829)
<Job Responsibilities>
 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.



<Necessary Skill / Experience >
 Thai nationality, Male/Female, age 23-30 years old
 Bachelor’s degree of pharmacy and have a pharmacist license
 At least 1 year experience as regulatory affairs officer.
 At least have basic knowledge in regulation, variation, pharmacovigilance
 Good command in English both in oral and written (with English test certification)
 Good computer literacy (MS office: Word, Excel, Powerpoints)
 Be able to work under pressure of deadline/ be a good team player

<Preferable Skill / Experience>
 Experience in project management

Languages skills
English: Conversational Level
Japanese: None

Workplace Area: BTS Ploenchit, Bangkok
Working Hour: 8:30-17:00 (Mon-Fri)

About the Benefits
Salary: 30,000–42,000THB

About the company
Products: Import & sell pharmaceutical products, and new drug registration, etc.
Business Type: Pharmaceuticals

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