Regulatory Officer - Germany

Role:

Regulatory Affairs Co Ordinator

Regulatory Affairs Officer – Clinical Trials - Germany

In partnership with its client CPL are currently seeking a Regulatory Affairs Officer for a permanent role based in a Clinical Research Organisation in Germany.

The Client:

My client is a leading Clinical Research Organisation, with a global presence. This position is based in Germany.

Fluent English and Germany is essential for this position. Additional language skills would be a benefit.

Job Requirements

Working within a highly qualified team you will prepare regulatory submissions for the country specific Regulatory Authorities and Ethics Committees for the region within which you work.  You will liaise with the authorities as appropriate regarding amendments and questions relating to start up activities.    

Job Responsibilities

• Working proactively 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 Manager.

 All applications will be treated with the strictest of confidence

CPL Contact:

To apply or for further information please contact Jenny Navan on +353 1 614 6072 or e-mail with you updated CV to jenny.navan@cpl.ie

Keywords: Quality, QC, QA, Quality Control, Quality Assurance, Clinical Trials, Clinical Research, GCP, Science, Germany, Clinical Research, CRA, Clinical Research Associate, Job, Opportunity, Career, Role, Vacancy

Keywords:

Quality |   QC |   QA |   Quality Control |   Quality Assurance |   Clinical Trials |   Clinical Research |   GCP |   Science |   Germany |   Clinical Research |   CRA |   Clinical Research Associate |   Job |   Opportunity |   Career |   Role |   Vacancy |