Interim Senior Manager, Regulatory Affairs
Our client is an ambitious and fast growing speciality pharmaceutical company with a range of innovative products already commercialised in the US and Europe and an exciting pipeline of new products in pre-clinical and clinical development.The need exists for an interim Senior Manager, Regulatory Affairs to assume responsibility to work on a number of products where the need is to help maintain the momentum as far as the ongoing development programmes and scheduled regulatory submissions are concerned.
The role is one that will interact with colleagues elsewhere in Europe and in the US alongside the necessary interactions with the Regulatory Authorities, particularly in Europe. The position will report to the company’s Head of European Regulatory Affairs.
The interim assignment will be of 6 months duration and will demand 4-5 days per week throughout this period.
Candidates are likely to have a scientific degree, possibly to PhD level, and have at least 5 years experience within European Regulatory Affairs. This implies an excellent knowledge of current European legislation and requirements for the development and maintenance of pharmaceutical products, particularly CMC requirements. Experience of working with biologics would be a real asset.
This is a very important assignment in an exciting company.
If this is of interest, please contact Interea at the earliest possible opportunity. We look forward to hearing from you.
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