*Regulatory Affairs Managerรหัส:52666

70,000 THB ~ 100,000 THBBTS (Sukhumvit Line)ผ่านมามากกว่า 3 เดือน

ภาพรวม

  • รายได้ต่อเดือน

    70,000 THB ~ 100,000 THB

  • ประเภทธุรกิจ

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

  • รายละเอียด

    - Liaise with the FDA and regulatory consultant(s) on matters pertaining to regulatory-activities, licenses and permits for new and existing products. Products include drugs,medical devices, food Products and cosmetics.
    - Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new Products based on regulatory expertise with regulations & processes.
    - Review technical dossier of new Products and prepare additional documents where necessary.
    - In-charge with the timely approval and renewal of product licenses, company licenses,pre- and post-approval variations, permits and other applications.- Handle post-marketing activities and yearly reporting requirements of company andproduct licenses.
    - Review and approve advertising and promotional items to ensure regulatorycompliance. And submit to FDA.- Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
    - Keep updated with FDA regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
    - Researching and implementing new upcoming GDP regulation. For medical device.

คุณสมบัติ

  • คุณสมบัติ

    [Must]
    ・Female Only age 35~45
    ・Fluent English skill to communicate with International R&D Manager(s) and staff In Japan
    ・Experienced of registering of drug
    ・Bachelor of Pharmacy

    [Advantage]
    - Experience of creation of ACTD format for new or generic drug.
    - Experience of drug, medical device and/or cosmetic product classification.

    [Personality]
    ・Flexible person for new jobs・With the sense of Team Work.
    ・If there is any problem, the person will come to the store and solve it on one's own.Speedy work
    ・Logical way of thinking

  • ความสามารถทางภาษาอังกฤษ

    Level 3 - Business Level

  • ความสามารถทางภาษา (อื่นๆ)

    English

ข้อมูลเพิ่มเติม

  • สวัสดิการ

    - Social Security Fund
    - Medical Allowance (2000 THB for each)
    - Annual Health Checkup
    - Car Depreciation (approx 5000 THB)
    - Gasoline Allowance (approx 5000THB)
    - BONUS (1-3 months, once per year)
    - Others

  • เวลาทำงาน

    9:00 ~ 17:00

  • วันหยุด

    - Sat, Sun
    - Public Holiday

  • ประเภทงาน