CTA Officer 621

In the context of a brand new project, we are looking for a consultant to join us asap on the following missions :

About us

Group 10

  • Responsible for overall planning and execution of regulatory and ethics submissions for assigned projects/countries (all regions especially Europe)/sites, which may include completion of submissions or notifications, as required
  • Direct and oversee short-term and long-term planning of regulatory submission initiatives
  • Develop and implement strategies for the earliest possible approval of regulatory submission
  • Responsible for review and compilation of the Clinical trial application dossier (including associated documentation)
  • Responsible for submission of the Clinical trial application dossier through the CTIS portal for Europe or another applicable regulatory portal
  • Responsible for providing advice and support to the project team for regulatory aspects of the clinical trials and late phase studies
  • Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Clinical Regulatory Affairs activities (update of Tracking tables, internal and external database)
  • Responsible for liaising with other departments on requirements for regulatory and ethics submissions
  • Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form
  • Prepare responses to inquiries / comments from regulatory authorities on the CTA dossier or related documents
  • Maintaining an up-to-date knowledge of the European and other applicable regulatory requirements and processes

Group 12

  • Education : Life science degree, pharmacist education is a plus
  • Strong knowledge of ICH/GCP guidelines or other relevant guidelines
  • Good understanding of Clinical trial regulation and the Clinical trial information system
  • Ideally EU / Global experience (2 to 3 Years)
  • Proficiency with computer systems
  • Strong verbal and written communication skills in English, any other language is a plus
  • Strong organizational, time management, interpersonal skills.
  • Team player spirit
  • Ability to work both independently and in a team environment