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Brunel

Regulatory affairs specialist

Heist-Op-Den-Berg - België - Life sciences - Pharmacie - Wetgeving - Academic Master
  • Brunel
  • Multiple regions
  • Permanent, Full-time
Published on Jobat.be 6 days ago

Regulatory affairs specialist

Are you someone who likes trying new things and gaining different experiences? Than life as a consultant might be your thing!

As a consultancy company specialized in Life Sciences, Infrastructure and IT we are looking for new consultants to join our team of experts. At the moment for example, we are looking for a regulatory affairs specialist to consult one of out clients.

Job description

  • Assists in compilation and submission of regulatory documents to the local regulatory authorities and - as applicable - to the European Medicines Agency (EMA) related to new applications, variations, renewals, etc.
  • Builds and maintains standard Regulatory Official Files as well as Marketing Authorization filing and approval binders according to local SOPs.
  • Ensures that regulatory databases and systems are kept updated and complete.
  • Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
  • Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
  • Ensures that artwork including all package components (leaflets, labels, outer cartons etc), is developed in a timely and correct manner and according to relevant Artwork Management procedures.

Profile

  • Post-secondary education in scientific science or equivalent.
  • Basic medical and scientific understanding and knowledge.
  • Basic skills and knowledge of local and EU medicines legislation and regulatory procedures.
  • Good interpersonal and managerial skills, capability of problem resolution and the ability to work in a team environment.

Offer

Our network and expertise make it possible for us to advance you career. Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 40 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.

Ofcourse we also offer you the salary package you deserve!

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    22 days left to apply

    Characteristics

    Offer

    • Permanent
    • Full-time
    • Group insurance
    • Meal vouchers
    • Individual hospital insurance
    • Family hospital insurance
    • Eco Cheque

    Apply before

    • 15 December

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