Regulatory Specialist: Belgium

Role:

Registration Specialist

A Regulatory Specialist is required for a leading Clinical Research Organisation based in Belgium.            

 Within this position you will be responsible for:

• Working pro actively as part of a project team you will coordinate all necessary activities required to gain Regulatory & Ethics Committee approval for clinical studies.
• You will be required to collate and prepare all documentation and dossiers for regional study approval in accordance with the relevant local legislations.  
• In addition you will complete all amendments and respond to submission related queries from the Clinical Teams.
• Regular contact with the designated personnel from Regulatory Authorities & Ethics Committees must be maintained in order to monitor the submission progress in accordance with study start up deadlines.
• As your experience develops, you may be expected to take the lead on regional projects, reporting directly to the Regional ISIS Manager.

Ideally, you will be degree qualified ( With a University degree in medicine, science, or equivalent ) and have previous experience in: 

• a Clinical Research Organisation with experience in submittals
• Knowledge of ICH GCP guidelines and expertise to review and evaluate medical data
• Demonstrate an understanding of regionally specific legislation surrounding ethics committees and submissions procedures and practices
• Have excellent interpersonal and presentation skills and the ability to interact at all levels in this client facing role
• Bi-Lingual – you must be fluent French or Dutch speaker with fluent English since all submission documents to sponsors and many authorities must be compiled in English
• You must have experience with Belgian submissions to ethics committees and regulatory authorities (critical)
• You must also have previous home-based experience
• You must be willing to travel to the Netherlands when required

For further information on this position or similar roles please contact me on Jenny.Navan@cpl.ie or call 00353 1 614 6072

Tagwords: clinical research, clinical research organisation, CRO, pharmaceutical, registration, regulatory affairs, study authorisation associate

Keywords:

clinical research |   clinical research organisation |   CRO |   pharmaceutical |   registration |   regulatory affairs |   study authorisation associate |