Our client, a biotechnology company with key therapeutic specialisms which include Oncology, are looking for a Regulatory Affairs and Drug Safety Manager, Europe.  The main purpose of the role is to ensure that all aspects of the Regulatory Affairs and Safety (RAS) function run smoothly in a reliable, timely, and accurate fashion and in accordance with the applicable legislative framework. To be successful in this position, you will need to demonstrate an in-depth knowledge of Clinical Research, including scheduling, managing resources, and co-ordinating team activities within a regulatory function (preferably on an international level). Demonstrable knowledge of the drug development/ registration process including planning, labelling, regulatory compliance, and reporting. Thorough knowledge of Clinical Trial regulations and guidance, and a good knowledge of regulatory start-up and filing procedures in Europe. Thorough knowledge of pre- and post-marketing safety reporting standards and procedures in Europe. Good working knowledge of Pharmacovigilance data, its tracking, and interpretation. Proven ability to develop appropriate risk / benefit analysis for presentation to external bodies

We at Phlexglobal value our employees, not only will you benefit from working with one of the leading CROs, we offer COMPETITIVE SALARIES, COMPANY CONTRIBUTORY PENSION SCHEME, PERSONALISED TRAINING and DEVELOPMENT and CAREER PLANNING to name a few. For more details please contact your Resourcing Team.

Phlexglobal is a leading quality driven Contract Research Organisation who only select the best. Ours is a people culture and we are committed to nurturing and training self-motivated, exceptional Clinical Research Professionals.

If this sounds like you and you have the desire, skills and tenacity to succeed within the Clinical Trials field then contact me now! If this job isn’t relevant for you but you would like to find out more about the roles we offer then please contact your Resourcing Team on 01494 720 420 ext 440 or email – Resourcing@phlexglobal.com

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