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Regulatory Associate Lead Document Management

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  • Regulatory Associate Lead Document Management

    Location: Antwerp, Belgium
    Type: Permanent
    Salary: €60,000 - €70,000 per annum (dependant in experience)

    Job reference: J23485

    Our client is a rapidly expanding biotechnology company based in Belgium, their focus is on the development of small molecule medicines covering a large therapeutic areas. With the speed of growth our client is looking to expand their Regulatory Affairs department and are wanting a Regulatory Associate Lead Documentation Manager to join their team.

    The successful Regulatory Affairs Lead will have the opportunity to work within a highly motivated and entrepreneurial team, with a dynamic work environment. You will responsible for managing the day to day regulatory documentation and compliance activities.

    Responsibilities will include though not be limited to:

    *Coordinate, develop, implement maintain and ensure the compliance of regulatory document management systems, tracking tools and processes.
    *Primary contact for an given client
    *Ensuring appropriate training and operational support is given, informing and advising the internal organisation on eCTD, e-submission platforms and reporting tools.
    *Assist in the preparation of defined procedural documents and processes

    Experience required:
    *5+ years of experience in regulatory affairs
    *Experience in documentation management and compliance
    *Data gathering, problem solving and analytical thinking
    *Strong verbal and written English, other languages would be desirable

    Keywords: Regulatory Affairs, Regulatory Document management, eCTD, Submissions, 5 years experience, systems, CRO, Biotechnology, Belgium.


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