REGULATORY AFFAIRS/SITE ACTIVATION MANAGER

Main responsibilities / Major activities

The Regulatory Affairs/Site Activation Manager operates within the Regulatory Affairs Department. His/her role is to ensure the fulfillment of all the legal requirements pertaining to clinical trials activation in countries where EORTC clinical trials are conducted.

The level of responsibilities of the selected candidate will depend on his/her experience and expertise in the field.

The role may include the following responsibilities:

  • Compile, submit and follow-up clinical trial applications according to the country specific applicable national laws
  • Ensure timely answers to questions raised by Competent Authorities and Ethic Committees
  • Provide regulatory advice to EORTC staff on applicable national legislations and regulatory procedures
  • Interact with Pharmaceutical Industry and Contract Research Organizations (CRO) for specific projects
  • Ensure at any time compliance with EORTC procedures in changing legal environment

Profile

  • Bachelor’s degree in life sciences or related field, with 3 years’ relevant experience including demonstrable experience in Site activation/Regulatory Affairs related to clinical trials environment (CRO or university/ hospital or pharmaceutical industry) or equivalent combination of education, training and experience
  • Familiar with the EU Clinical Trials Regulation N° 536/2014and knowledgeable on the new upcoming European regulations
  • Ability to cope with and meet tight timelines when required
  • Able to manage multiple tasks at the same time
  • Able to work independently as well as part of a team
  • Demonstrated good organization, communication and time-management skills
  • Excellent attention to detail and accuracy
  • Proficient verbal and written English, other language is an asset

Application form


*Compulsary fields
Application should be sent in English

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