Regulatory Affairs Supervisor ID:58034

67,000 THB ~ 80,000 THBBTS (Sukhumvit Line)2个月 ago

概述

  • 薪资

    67,000 THB ~ 80,000 THB

  • 产业类别

    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)

  • 工作内容

    - Has experience in filing and manage at least one new drug application until successfully obtained the approval as a project leader
    ‐ 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.
    - Experiences in PV and/QA function are plus.

资格

  • 应征条件

    【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

  • 英文

    Level 3 - Business Level

  • 其他语言

    English

附加信息

  • 福利制度

    - Pharmacist allowance: 5,000 Baht/Month
    - Phone allowance :1,000 Baht/Month
    - Transportation allowance : 1,000 Baht/Month
    - Social Security
    - Medical Insurance
    - Health Check Up
    - Company party
    - Bonus (Provided 1 month in 2022)
    - Others

  • 工作时间

    8:30 ~ 17:00

  • 假日

    - Sat, Sun
    - Public holidays

  • 职业类别

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