Senior Associate Regulatory Affairs

  • Professional
  • Pharmaceutical
  • Regulatory Affairs & Pharmacovigilance
  • Vast (1,0 fte), Vast (0,8 fte)
  • Netherlands
  • Pharmaceutical Company

Become the Senior Associate Regulatory Affairs and coordinate regulatory submissions for approval of NCE's, line extensions, new indications, new patient populations and more. Be the one to maintain current registrations and advise on all matters relating to local drug law/regulations as well as company policies. 

Read further to discover the main responsibilities of this role!

You will be responsible for

  • Submission of dossiers for medicinal products to be registered via national procedure, mutual recognition procedure or central procedure.
  • Maintenance of licences of medicinal products registered via mutual recognition procedure or central procedure (e.g. submission of variations and labeling changes).
  • Coordinate the update of packaging items for registered products to be in compliance with labeling and packaging guidelines.
  • Share regulatory knowledge with colleagues.
  • Provide support concerning regulations and labeling of clinical trial material
  • Do you have

    • A Bachelors/University Degree in Health care-related of life science field or equivalent demonstrated experience
    • Excellent communication skills
    • Team player tendencies
    • Comprehensive knowledge and understanding of local and Global and EU regulatory legislation

    Other preferences:

    • Dutch language skils (written and verbal)
    • English language skills (written and verbal)
    • Living in the Netherlands

    About our client

    This pharmaceutical company is based in Utrecht and focuses specifically on the therapeutic areas (diabetes, cancer, immunology, pain, and neurology). Their values include intergrity and respect while also striving for innovation in the field and the continuous development of high-quality products. They aspire to continue the search for the next big discovery to improve the lives of people all over the world. 

    Contact a consultant today to hear more about this company and their inspirational team. 

    Deel deze vacature

    Joan van Droffelaar

    Consultant Medical

    M (06) 53 662 681

    T (035) 543 00 21

    Stuur een mail


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