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Regulatory Affairs Officer - Sittard

Function Group: Quality/RA / RA Officer

Organization

For a dynamic pharmaceutical consultancy organisation we are looking for an ambitious Regulatory Affairs Officer. Our client has been offering pharmacovigilance, regulatory affairs, clinical study management and quality services to pharmaceutical companies for over 20 years. They are looking for someone with a good combination of technical knowledge, especially in the field of international laws and regulations.

Function

As a RA Officer you are responsible for the following:

  • The registration procedures of existing products to retain marketing authorisations
  • The registration procedures of new products, national and European. You do this together with the RA Manager
  • Submitting the registration dossiers
  • You keep the current registration files up to date make changes where necessary
  • You work closely with the RA team and ensure that all relevant matters for the registration process (both external, internal and the authorities) are accurately and timely communicated

    Requirements

    You have the following skills and experience:

    • You have between three and five years of experience with regulatory affairs work in the pharmaceutical industry
    • You have knowledge of national and European legislation, regulations and RA guidelines
    • You have experience with CTD registration dossiers for medicines and the electronic submission of dossiers
    • You have good computer skills and have great working knowledge of Word, Excel and preferably also MS projects
    • You have a strong command of the English language (Dutch is a nice addition)

    Offer

    They offer a very interesting salary package, good career opportunities and flexible working hours in a dynamic environment with a high team spirit.

    Application

    Martin van der Velden
    Consultant

    +31(0)23-7548660
    +31(0)6-83656209
    m.vandervelden@qtcrecruitment.com

    Apply
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