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Job Location | Cambridge |
Education | Not Mentioned |
Salary | 400.00 - 450.00 per day |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Contract , full-time |
OUTSIDE IR35 | GLOBAL CMC MANAGER | BIOLOGICS | ONCOLOGY Regulatory Affairs Manager CMC | BIOLOGICSA top 10 global pharmaceutical company are looking for a skilled strategic and operational CMC Regulatory Affairs Manager to join the UK team, on a remote basis. They have one of the UKs most exciting oncology product portfolios for a large pharma and are knownfor their rolling contracts past the end dateAs the Regulatory Affairs CMC manager you will play a part of project management where you will be responsible for the coordination and maintenance of CMC submissions for required products in the Oncology portfolio. On the other hand you will be responsiblefor the actual CMC Biologic submissions, Globally. This is a full lifecycle role and will be looking at Module 1-3 from clinical development to post approval commercialisation.What you will need to succeedYou will need to have at least 5-8 years Regulatory experience, with at least 3 years experience within a CMC Regulatory Affairs position within Biologics/Biosimilars/ Synthetics. You will be experienced with strategic CMC full lifecycle activities, havingclinical development CMC experience would be desirable. You will need to have global exposure as they are a very large client and will be working with 2-3 countries at any given time. Having oncology experience is desired but not a must.What you will get in returnThis is an out of scope, 12 month contract with scope for extension. Global exposure in a top 10 pharmaceutical company on exciting oncology products. This can be fully remote but must have right to work in the UK.What you need to do nowIf this role is something you may be interested in please click "apply now" to forward on an updated version of your CV. Please contact Julia Bowden for more information