Regulatory Affairs(Senior Level)ID:53058

40,000 THB ~ 80,000 THBBTS (Silom Line), MRT LineOver 3 months ago

Overview

  • Salary

    40,000 THB ~ 80,000 THB

  • Industry

    Manufacturing(Cosmetics/Healthcare), Manufacturing(Pharmaceutical/Medical Equipment)

  • Job Description

    -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.
    -Performing various other tasks as assigned by supervisors.

Qualifications

  • Requirement

    -Male or Female,Thai national,Age 27-40 years old
    -Bachelor’s Degree in Pharmaceutical Sciences
    -At least 5 years of experience in regulatory affairs
    -Have Pharmaceutical license(Preferable)
    -Good command of English, both writing and speaking

  • English Level

    Level 3 - Business Level

  • Other Language

    English

Additional Information

  • Benefit

    - Position Allowance
    - Transportation
    - BONUS
    - Insurance
    - Provident Fund

  • Working Hour

    08:30 ~ 17:30

  • Holiday

    - Weekends (Sat-Sun)
    - Public Holidays (Thailand)

  • Job Function