Associate Director, Regulatory Affairs
Description : 25 Mar, 2023
Associate Director Regulatory Affairs - Oncology Cell Therapy Cira GBP150,000 Package Compass Life Science have partnered with one of the world's leading Biotech's in their search to appoint an Associate Director of Regulatory Affairs focused on Oncology - Cell Therapy. You will be key part of the Regulatory Affairs team, across the ACE region. Our client is a specialist in advanced therapeutics and is in an exciting stage of its history with multiple planned launches planned, due to a hugely successful track record delivering excellence for their customers. This is a key hire for the organisation and as such the right candidate must be an experienced Associate Director of Regulatory Affairs with experience in Oncology. In the role you, will be responsible for regulatory strategy for advanced therapy medicinal products that treat cancer in EU and core international markets (Switzerland, UK, Australia and Canada,) Knowledge and Experience Defining the regional regulatory strategy for development or marketed products in conjunction with regional director. Interacts with the Global Regulatory Lead to agree and ensures delivery of the regulatory strategy in ACE for both development and commercialised medicinal products. Responsible for the preparation and/or oversight of complex regulatory submissions which require interaction with cross-functional teams to ensure optimal execution. Prepares and/or co-ordinates submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. Prepares and/or co-ordinates regulatory documentation to support early phase development which may include Clinical Trial Applications/ amendments and Paediatric Investigation Plans. Location Uxbridge or Cambridge Contact Details Offering a very competitive base salary and benefits package, if you are interested in learning more, please contact me directly today as we are looking to appoint as soon as possible. For further information please contact me , or phone (0) . If you would like a call back, please email or text (0) Referrals Compass Associates Ltd trading as Compass Life Sciences are acting as a Recruitment Consultancy for this Permanent Vacancy; We offer up to GBP1,000 worth of Amazon vouchers for each successful recommendation.
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