Regulatory Affairs (Pharmacist)ID:74432

40,000 THB ~ 70,000 THBキングカエオ - スワンナプーム King Kaew- Suvarnabhumi1日 前

概要

  • 給与

    40,000 THB ~ 70,000 THB

  • 業界

    Manufacturing(Chemicals/Materials)

  • 仕事内容

    [Product]: Chemical and Medical Device

    Responsibilities:

    - Preparing registration dossiers according to local regulations and FDA requirements.
    - Providing support in relation to permits, licenses, approvals and all registrations, including FDA, BOI, OAE and DIW and applying and reviewing the relevant permits/licenses as required by law/regulations.
    - Managing Thai FDA comments during the submission process and ensuring that products will obtain registration approval within related timelines.
    - Filing documents for variation amendments.
    - Ensuring that all key products will be submitted following the strategic plan.
    - Liaising with the regulatory authorities to obtain registration certificate approval or amendment approval.
    - Ensuring that products comply with the current laws and regulations.
    - Providing support in terms of product importation by ensuring that all documents are aligned with local requirements.
    - Arranging and updating packaging artwork of registered products.

求めている人材

  • 応募条件

    【Must】
    - Bachelor's Degree in Pharmacist
    - Hold a Pharmacy License
    - Good command of English (able to communicate)
    - Happy to work with the documentation tasks
    - Have a license and own car

    【Advantage】
    - Experience in FDA application
    - Experience in coordinate with FDA about the medical devices import
    - Experience in coordinating with government offices

  • 英語

    Level 4 - Conversational Level

  • その他言語

    English

その他

  • 福利厚生

    - Travel allowance (actual claim)
    - Provident fund
    - Social security
    - Life & Accident Insurance / Health Insurance
    - Bonus

  • 就業時間

    08:30 ~ 17:30

  • 休日

    - Sat, Sun
    - National holiday

  • 職種