Candidates

Quality Assurance Officer

Quality Assurance officers ensure that a companies Standard Operating Procedures (SOPs) are delivered and implemented in line with currently regulatory practices. A QA Officer needs a thorough understanding if ICH GCP and will often come from a Clinical Operations or CRA background.

QA Officers work independently from the Clinical Research Teams and are also responsible for conducting audits in-house and at study sites.

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Job of the week - Senior Contract Regulatory Professional

Our client is a leading Pharmaceutical company. This R&D group have a large and dynamic European Regulatory Affairs Department responsible for the regulatory affairs work for the CNS R&D in Europe, Turkey, CEE region, Israel, South Africa, New Zealand and Australia.

The work has several aspects;

  • Communication to the Global Regulatory Teams and the supporting functions for regulatory submissions, such as clinical;
  • Working with the local operating companies within the^allocated region and external communication to regulatory authorities in the regions and to the EMEA. The group covers both developmental compounds not yet licensed and the maintenance and further development of marketed products. The prime responsibility for compounds is with the European Regulatory Liaison (EURL) who is responsible for the regulatory activities in the region and inputs to the global regulatory aspects for the compound.Regulatory consultants will work for an EURL or a global regulatory leader in the CNS therapeutic area or in the mature products area. They will work on the practical aspects of the compounds assigned from clinical trial applications (CTA’s), ASR’s, requests for scientific advice, MAA preparation, variations, renewals, PSURs etc depending on the life cycle of the compounds assigned. They may work on one or several compounds depending upon the work required for any compound at the time. Their work will be assigned and monitored by the EURL or theglobal regulatory lead responsible for the consultant.Eligibility to work in the EEA is required