The Regulatory Affairs Assistant (RAA) works closely with the Regulatory Affairs Manager (RAM). They ensure that both the clinical trials which fall either under the Directive 2001/20/EC or the EU Regulation N°536/2014 when applicable, and other clinical studies which are run under the internal Sponsorship are authorized and conducted in accordance with the European directives and regulations, international guidelines, and national laws when applicable.
The tasks and responsibilities listed below might not be applicable for all projects, additional tasks and responsibilities might be assigned to the RAA according to his/her skills and qualifications.
Duties and Responsibilities:
- Compile, submit and follow-up clinical study applications to Ethics Committees and/or Competent Authorities (initials, amendments, end of clinical study if applicable, final study report) in line with regulatory requirements and applicable national laws across different countries;
- Ensure timely answers to questions raised by Competent Authorities and/or Ethics Committees;
- Ensure appropriate management of study documents such as filing, processing and quality control;
- Update and maintain the regulatory specific tracking system;
- Act as a point of contact for Institut Jules Bordet on regulatory matters;
- Organize meetings, prepare agendas and minutes;
- Attend meetings and/or teleconferences on behalf of the RAM.