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    Regulatory Affairs Specialist - West Flanders, België - Michael Page

    Michael Page
    Michael Page West Flanders, België

    4 dagen geleden

    Michael Page background
    Beschrijving

    As a successful Regulatory Affairs Specialist - Pharma - BeNeLux you will have the following responsibilities:

    • Prepare, submit, maintain and record technical and regulatory documentation
    • Ensure up to date EMEA document management system
    • Collect information on products to create and update the product regulatory information
    • Interpret regulatory requirements to ensure compliance of the products
    • Provide support on compliance topics for the supply of raw materials to the pharmaceutical industry
    • Participate in and support regulatory audits and inspections
    • Monitor and assess changes in regulations, guidelines, and standards
    • Support Change Control process
    • Maintain communication and relation with regulatory stakeholders

    As a successful Regulatory Affairs Specialist - Pharma - BeNeLux you will have the following requirements:

    • Degree in life sciences or related fields
    • +5 years of experience in regulatory documentation within the chemical or the pharmaceutical industry
    • Deep knowledge of pharmaceutical industry requirements and regulations
    • Strong expertise with European National Competent Authority requirements with distribution of ingredients and row material
    • Autonomous profile but team player at the same time
    • Able to work at a strategical and operational level at the same time
    • Fluent in English and Dutch. French is a plus

    As the successful Regulatory Affairs Specialist - Pharma - BeNeLux, you will have a Belgian permanent employment contract with:

    • An attractive salary including an annual bonus based on performance and a complete package of extra legal benefits (Company Car, Net Allowances, Insurances, Extra Days Off...)
    • The chance to join a dynamic and positive multicultural organization driven by results
    • The possibility to be part of an international and expanding company with multiple growing opportunities.
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