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Senior International DRA Project Manager - Oferta z Jobs.pl

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Senior International DRA Project Manager

Nr ref.: /JOBS.pl

  • Reference Number: 895107-P

    Type of placement: Permanent

    Location: Basel area, Switzerland

    Main Responsibilities:

    Provides regulatory strategy for the international countries (outside the following countries: US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
    Maintain regulatory knowledge for international countries (new registrations, variations & renewals of marketed products)
    Liaise and coordinates all documentation, submissions and activities with affiliates / partners for NCE dossiers and life cycle of marketed products
    Responds to Health Authority questions in coordination with Global DRA Project Leader and project team
    Applies for the preparation and shipment of registration samples
    Coordinates the archiving of submitted registration dossiers and other relevant Health Authority communications
    Evaluates and reviews the regulatory activities of potential and existing business partners contracts and quotations
    Deputizing the Group Leader, as necessary
    Opportunity to mentor the Junior International DRA Project

    Qualifications and Experience:

    Degree in life science and at least 5 years previous experience working in regulatory affairs, preferably with regions outside of the EU and US
    Good knowledge of international regulatory legislation and guidelines
    Ability to work in multicultural environment
    Excellent communication, interpersonal, negotiation and problem solving skills
    Capable of working independently as well as effective team player
    Accuracy and good project management skills
    Excellent command of spoken and written English, other languages are advantage
    Management experience is an advantage


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