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Regulatory Professionals
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Gloucester, Gloucestershire
Regulatory Affairs Manager
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Salary: £55 - 60 |
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Overview
Regulatory Affairs Manager 12 Month Contract Cambridgeshire and London Based Offering up to 60 Per Hour Oncology Regulatory Professionals are working with a leading biotechnology firm, who are looking for a Regulatory Affairs Manager, on a 12-month contract. Working out of either their Cambridge or London offices, you will support one or more products from a regional and extended EU regulatory perspective. You will be responsible for acquiring and maintaining all the required licenses in order to support clinical trials and further development of investigational medicinal products and market commercially approved medicinal products as well as regulatory compliance, with a focus on patient safety. Job Responsibilities Include; Develop and execute EU Regulatory strategy. Plan and manage Regulatory submissions for products within the portfolio in compliance with global filing plans and local regulatory requirements. Expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans. Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to products. CTA and early development focus. Candidate Requirements include; Must be eligible to live and work in the UK Life Sciences degree or equivalent Strong communication skills - written and oral A minimum of 5 years Regulatory experience If this position is of interest to yourself please call Ben at Regulatory Professionals on 0118 952 2797 or alternatively send your CV to This job was originally posted as www.totaljobs.com/job/89689810