• 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)
  • Preparation of whole documentation for submission to Authorities (cover letter, application form, comparative table, review of protocol, Inform Consent Form, …)
  • Database update



  • Education : Life science degree, (higher graduate degree in a science field)
  • 3 years in management of submission of Clinical Trials to Heath Authorities
  • 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

Technical Skills

  • Knowledge of EU / International submission of Clinical Trials Application (CTA) to Competent Authorities and/or Ethics Committee (initial submission, amendment substantial or not substantial, notification (e.g.: DSUR, First visit first patient, …)
  • Database update as Veeva Vault, or other)
  • Analytical skills
  • Ensure compliance of files with regulatory requirements

Clinical Trial Application (Freelancer)