Interim Regulatory Affairs Manager : Europe

Our Client is an emerging American pharmaceutical company, in the early stages of planning and developing its organisation and business activities  in Europe.  Their lead compound is a “first-in-class”  and is expected to achieve regulatory approval in a number of interesting and challenging therapeutic areas.

Reporting to the Regulatory Affairs Director (UK based), this role has responsibility for assisting in the development and implementation of the company’s European regulatory strategies, such that the process of approval in Europe is optimised in terms of competitiveness of the product label and timeliness of regultaory approval.

Duration of the assignment will be 6-9 months, ideally 4-5 days per week, some of which can be performed from a home base.   The European offices are based close to Oxford.

Candidates must have at least 5 years experience in European Regulatory Affairs and be familiar with submissions for NCE’s through National, MRP/DCP and Centralised procedures.

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