Regulatory affairs specialist

PUB285009

Vrouw in labo

Over deze funtie

  • Markt: Life sciences
  • Branche: Pharmacie
  • Expertisegebied: Wetgeving
  • Standplaats: Antwerpen

Wat is vereist?

  • Uren per week: 40
  • Opleidingsniveau: Academic Master
  • Sluitingsdatum: donderdag 17 december 2020

Over deze functie

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.

  • 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.

Over jou

  • 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.

Wat wij je bieden

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!

Start je sollicitatie hier!

Solliciteren bij Brunel gaat snel en gemakkelijk. Wij ontvangen graag het volgende van jou:

  • Recent CV of LinkedIn-profiel
  • Motivatiebrief (optioneel)
  • Certificaten (optioneel)
  • Referenties (optioneel)
Solliciteer

Vragen over de vacature?

Jouw Talent Hunter, Max Temmerman licht graag alles toe over deze vacature. Wanneer je contact opneemt, verwijs naar het volgende vacaturenummer:
PUB285009

Talent Hunter

Max Temmerman
Brunel Belgium Mechelen
m.temmerman@brunel.net

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