Candidates

Regulatory Affairs Officer

The Regulatory Affairs department is the link between the company and the regulatory bodies. To work in this department youwill need a good eye for detail as you will be involved in the writing and preparation of documents that will be approved by the regulatory bodies. In the Regulatory department you could be involved in all stages of the drugs devcelopment all the way through to its licencing.

Furthermore, once the product is in the marketplace you will also ensure that the product licences are kept up to date and that any renewals or variations and changes (e.g any changes in labelling and packaging or in the patient information leaflets). In some companies you will also get the opportunity to have a major input into the drug development process and will review and clinical development plans to ensure that they comply with the relevant guidelines.

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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