Local Regulatory Affairs Associate -Belgium or Netherlands

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Bedrijfsinformatie

  • PRA 
  • Utrecht 

Omschrijving

The Local Regulatory Affairs Associate (LRAA) is responsible for preparing, submitting and following up on initial and amended Ministry of Health (MoH), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) you will be responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval. The LRAA is responsible for ensuring that all importation and exportation requirements are met for Investigational Product and any other clinical trial supplies needed for the trial within their country. The LRAA is also responsible for providing review of the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements. Additionally the LRAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements.To be considered for the Local Regulatory Affairs Associate position you must have a BA/BSc (or equivalent) in a related science field along with some experience working within regulatory affairs within either a pharma or CRO. Experience of Regulatory submissions is required.This position can be full time or part time, based in our our office in Mechelen, Belgium or Utrecht, Netherlands, Fluency in French, Dutch and English are essential.Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

Vast contract, onbepaalde tijd uur per week

Vereisten


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Vacatureinformatie

  • Techniek  
  • 12-03-2014 
  • Full time baan  
  • in overleg, afhankelijk van kennis en ervaring 

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