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Advanced Regulatory
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Maidenhead, Berkshire
Regulatory Affairs Snr Manager CMC for Biologicals - Cover early & late phase development projects
Overview
Regulatory Affairs Senior Manager CMC for Biologicals - Cover early & late phase development projects Location : Near Maidenhead, Berkshire, South-East This role is good mix of strategic input, global project management and covers early & late phase development and global registration activities. Promotion prospects are very strong and there are options available to become a technical CMC specialist or move into people/team leadership. ADV Talent Partners have a new Regulatory Affairs CMC role based at the Head Office of one of the world’s most dynamic and successful Biotechnology Company. The salary and package is exceptional for this role, including a strong basic salary bonus shares options full healthcare and medical strong pension high level re-location package included. There is also a great onsite restaurant, flexible working hours, extensive parking available, good transport links and many company clubs & events to ensure a great work-life balance Role / Description: You will be the regional lead providing regulatory affairs CMC insight and intelligence on the regions to foster best approaches, from developing regional CMC RA strategies through to the preparation and submission of CMC documentation for development and registration / lifecycle in EU and all major Global regions (including Asia Pac, LatAm and China). You will need to be strong in leading regional CMC strategies through to fulfilment, optimising timelines where possible by working well with cross functional departments and your colleagues in Global (Therapy) Regulatory. There are many reason to join this amazing organisation including a dynamic, creative & energising culture, an expansive and strong pipeline, multiple opportunities for personal development and the freedom and flexibility to have a strong strategic input into your projects. You will need at least 6 years of Regulatory Affairs CMC experience and be ready for a role where you have real autonomy, scope and responsibility for a varied Biological product portfolio, working on indications in different stages of development. ___________________________________________________________________________ To apply , please send a full CV to CVAdvTalent.com , or alternatively, contact Theo Moore on 44 (0)207 801 3384 . 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.