Job Description
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.
Job Requirement
<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