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Regulatory Affairs/Site Activation Manager

  • Locatie:

    Brussel, België

  • Contactpersoon:

    Amandine Planche

  • Contractsoorten:

    Contract

  • Telefoon contactpersoon:

    +32 10 68 53 34

  • Bedrijfssectoren:

    Life Sciences, Clinical Research

  • E-mail contactpersoon:

    amandine_planche@oxfordcorp.com

For one of our client located in the East of Brussels, we are looking for an experienced Regulatory Affairs/Site Activation Manager.
Hybrid working opportunity (2-3 days/week on site at client's location in Brussels is required).

Job Description

As Site Activation/RA Manager, you ensure that all the regulatory requirements pertaining to clinical research are fulfilled.

Responsibilities

  • You prepare master packages for international clinical trial applications
  • You provide regulatory advice to our client's staff on applicable legislations (international and national) and regulatory procedures
  • You compile, submit and follow-up clinical trial applications according to applicable national laws
  • You ensure timely answers to questions raised by Competent Authorities and Ethic Committees
  • You interact with Pharmaceutical Industry and Contract Research Organizations (CRO) for specific projects
  • You ensure at any time compliance with our client's procedures in changing legal environment
  • You contribute to and maintain databases for assigned trials.
  • You contribute to training/coaching of new regulatory team members

Requirements

  • You have a university degree in life sciences or related field, with 3 years of relevant experience including demonstrable experience in Site activation/Regulatory Affairs related to clinical trials environment (CRO or university/ hospital or pharmaceutical industry).
  • You are familiar with the EU Clinical Trials Regulation N° 536/2014 and knowledgeable on the new upcoming European regulations
  • You are fluent in English. Any other language is an asset
  • You have the ability to cope with and meet tight timelines when required
  • You are able to manage multiple tasks at the same time
  • You are able to work independently as well as part of a team
  • You demonstrate good organization, communication and time-management skills
  • You have an excellent attention to detail and accuracy
  • Existing right to work in Europe is required

Benefits

  • Fulltime position
  • Open for employee and freelance profiles

Vacancy number 20648

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