Regulatory Affairs Manager

    Ditayangkan 22/October/2016



    • Requires suitable level of experience within a broad range of Regulatory Affairs project with sound knowledge of Indonesia Regulatory Procedures (Drugs/Biologics)
    • Responsible for providing to stakeholders and advising clients on strategic regulatory considerations for non clinical and clinical (phase I –IV) product development, study design and such as review of relevant regulatory precedents for evolving standards, product label key massaging and rigorous regulatory review for successful registration.
    • Prepared the dossier according ACTD and set up the submission, manage the performance within agreed timeline and budget.
    • Maintain excellent communication and collaboration with Global Regulatory/Regulatory team, other stakeholders as well as relevant colleagues from other region/branches.
    • Min. Bachellor's Degree in Pharmacy from reputable University (Apothecary Profession)
    • Min. of 3 years experience in similar position from pharmaceutical company
    • Familiar in dealing with government institution related pharmaceutical business (Kementrian Kesehatan, BPOM)
    • Have a strong leadership in managing a team
    • Excellent in English both written and oral
    • Computer literate
    • Can work under pressure, Have excellent attitude, Self initiated

    Tutup pada 05/November/2016

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    UOB Plaza Thamrin Nine Lantai 27, JL MH Thamrin No. 10, Jakarta 10230, Indonesia

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