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Advanced Regulatory
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Maidenhead, Berkshire
Regulatory Affairs, CMC Global Regulatory Leader - Berkshire, UK
Overview
Regulatory Affairs, CMC Global Regulatory Leader - Berkshire Do you want to take the lead for global biological development projects? This is a rare and unique role where you can take the lead for Global registrations for Biological products in mid and late stage development through to registration and Global expansion My client is a Global Biotechnology company with a pipeline of nearly 20 indications in development, with 5 major product registrations planned in the next 2-3 years. They are recruiting for a bright and ambitious Regulatory CMC professional to take the lead on developing global regulatory CMC strategies for mAbs in development guiding them through both EU and US registrations. Location: Berkshire, easily commutable via car or public transport. This highly efficient and extremely successful medium sized Biotechnology company has developed a hugely impressive pipeline of large molecule biologicals in mid and late stage of development. There are a number of potential blockbusters due for filling in the EU and USA over the next 1-3 years. As a result my client is now seeking a highly experienced CMC professional with a biological background gained through experience in either EU or US markets to take the lead in setting global strategies and coordinating complex submissions for the US, Europe and major markets. This is a highly visible role that requires strong levels of leadership for multiple cross-functional project teams and strong organizational and analytical skills to drive and provide strategic / operational regulatory CMC direction. Your duties will include responsibility for leading global CMC regulatory strategy for biologic development of projects and marketed products. This will include HA meetings and negotiations for FDA and EMA. You will also lead and matrix manage for internal & external teams on assigned projects for the preparation and review of IND/IMPDs, NDA/BLAs and EU and International MAAs. With this excellent role comes an excellent package which includes: a high level basic salary, bonus, car allowance, full re-location package to Berkshire with expectations that you will take the lead for Global projects. You must have knowledge of working within European Regulatory Affairs specifically as applied to biotechnology products. To Apply To apply , please send a full CV to CVAdvTalent.com , or alternatively contact Theo or Oli on 44 (0)207 801 3384 or 44 (0)207 801 3388 . We are assigned these roles by our client and will provide you with support throughout the hiring process. About Advanced Search & Our Network Advanced Search , has a network of affiliated companies including ADV Regulatory , and ADV Talent Partners . Together, we are specialists in Regulatory Affairs and Life Sciences recruitment especially around mAbs and biologicals for roles in R&D and Commercialization and have been established and hiring in this area since 2005. Our Regulatory Affairs team know their subject matter areas and our mission is to help you grow your career each and every step of the way. We have helped many of today's leading companies develop strong regulatory sciences functions and are known for hiring complimentary teams that work well with each other, at owner-contributor, strategy leading and people management levels. Contact us today to see how we can help you make that next career move on 44 (0)207 801 3380 All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-pharmaceutical community.