Regulatory Affairs (International)

    Ditayangkan 04/November/2016

    www.jobstreet.co.id

    DESKRIPSI PEKERJAAN

    Requirements:
    • Candidate must possess at least a Bachelor's Degree, Pharmacy/Pharmacology or equivalent from the reputable university with GPA min 3,00
    • At least 2 year(s) of working experience in Internatioanl Regulatory Affairs (for Export)
    • Age : 25-30 years old
    • Excellent communication skills,  Fluent in English both oral and writen
    • Responsible to generate regulatory strategies to support business strategies and market access
    • Applicants must be willing to work in Cipete Raya,Jakarta Selatan.
    • Preferably Supervisor / Coordinators specializing in Healthcare - Pharmacy or equivalent.
    • Full-Time position(s) available.
    Responsibilities:
    • Ensuring that a company's products comply with the regulations of the MHRA
    • Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exporting to; collecting, collating and evaluating scientific data that has been researched by colleagues
    • Developing and writing clear arguments and explanations for new product licences and licence renewals
    • Preparing submissions of licence variations and renewals to strict deadlines
    • Monitoring the development process related to the product under the exported product pipeline
    • Prepare the anual budget for regulatory department
    • Monitoring and setting timelines for licence variations and renewal approvals
    • Planning and developing product trials and interpreting trial data
    • Advising scientists and manufacturers on regulatory requirements
    • Negotiating with regulatory authorities for marketing authorisation
    • Maintains a profesional relationship with Health Authorities and players of similar insdustry
    • Act as project management officer to manage the compliance of the existing product with the approval from BPOM
    • Handle quality assurance compliance for overseas such as complaint, recall, return, inspection.
     
     

    Tutup pada 18/November/2016

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    Address

    Jalan Cipete Raya, Jakarta Selatan, DKI Jakarta, Indonesia

    Kesimpulan Review

    Pros
    • Produk berkualitas baik, membuat produk tidak hanya terkenal di Indonesia, tetapi telah menjangkau hingga ke dunia internasional. Gaji juga sudah sesuai.
    • Banyak sekali yang bisa saya pelajari di sini, terutama mengenai bisnis. Produk sudah sangat terkenal di Indonesia, bahkan pengiriman produk sekarang sudah sampai luar negeri.
    Cons
    • Namanya bekerja di dalam pabrik, tentu saja daripada otak yang lebih digunakan fisik. Waktu kerja panjang sementara waktu istirahat yang diberikan tidak terlalu banyak.
    • Lebih berat di pekerjaan dibandingkan dengan waktu istirahatnya. Pekerjaan pun cukup berat dan dibutuhkan ketelitian, sebagaimana bekerja di pabrik pada umumnya.

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