Regulatory Affairs Dept ManagerID:33775

90,000 THB ~ 120,000 THBBTS (Sukhumvit Line)Over 3 months ago

Overview

  • Salary

    90,000 THB ~ 120,000 THB

  • Industry

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

  • Job Description

    - Responsible for company’s licenses, products license renewal, and amendment
    - Lead, plan, and provide strategies for regulatory submissions for new products and variation
    - Closely track and monitor projects and submissions progress and report on status to senior management executives
    - Develop professional relationships with TFDA staff and proactively monitor relevant governmental bodies to identify changes in legislation or regulations
    - Keep abreast of changes in the regulatory environment to assure accuracy
    - Review and check the accuracy of overseas COA and prepare Thai version of COA for customs clearance procedures
    - Support sales and marketing colleagues and customers by providing adequate and relevant scientific information
    - Support QA and PV activities including other related tasks as necessary

Qualifications

  • Requirement

    - Male or Female, Thai nationality, age between 30-45
    - Bachelor's Degree or higher in Pharmacy, Pharmaceutical or a related field
    - Work experience in handling declaration process with FDA department
    - Having a strong connection with FDA department
    - Ability to communicate in English

  • English Level

    Level 5 - Beginner Level

  • Other Language

    English

Additional Information

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