This job is closed

Regulatory Affairs Officer (RA)ID:42940

50,000 THB ~ 80,000 THBBangkok ALL
  • Job Category

    Medical Technologist, Other (Medical/Welfare), Pharmacist/Nurse/Doctor

  • Industry

    Medical & Healthcare

  • Job Description

    - Regulatory affairs officers ensure appropriate licensing, marketing and legal compliance of pharmaceutical and medical products, in order to control the safety and efficacy of products. (combining knowledge of science, law and business to ensure products that are developed, manufactured or distributed by a range of companies, meet the required legislation
    - Ensure company's products are in compliance with MHRA regulations
    - Keep up-to-date with international legislation, guidelines and customer practices in all countries
    - Develop and write clear arguments and explanations for new product licences and licence renewals
    - Prepare submissions of licence variations and renewals to strict deadlines
    - Plan and develop product trials and interpreting trial data
    - Advise scientists and manufacturers on regulatory requirements
    - Provide strategic advice to senior management executives throughout the development of a new product
    - Undertake and manage regulatory inspections
    - Review company practices and provide advice on changes to systems
    - Negotiate with regulatory authorities for marketing authorisation

  • Requirement

    - Male or Female, Thai national, age between 28-45
    - Having pharmacist license is a must
    - Good command of English for business
    - Considerable understanding of legal and scientific matters
    - Good awareness of legislation governing the approval of products

  • English Level

    Communicative

  • Other Language

    English

  • Working Hour

    0900 ~ 1745

  • Holiday

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

  • Benefit

    - Social Security Fund
    - Medical Insurance
    - BONUS
    - Transportation Allowance

This job is closed