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London, Greater London
Senior Manager Regulatory Affairs CMC, NBEs, UK, M4 Corridor
Overview
Senior Manager Regulatory Affairs CMC - Lead Submissions for NBEs, UK, M4 Corridor This is a permanent role leading submissions for NBEs in the EU and the rest of the world for an international pharmaceutical company based in the UK, South East of England. Our client is an R&D driven, fast-moving, global Biotechnology Company with a pipeline of over 20 products in development. This organization over the years has pushed the boundaries of what is possible in order to make a real difference for patients’ lives. They have some exciting biologics coming in Ph2, Ph3 and a number of products in early development. The team is expanding, and this is an opportunity for a Snr Manager to join and lead as assigned some of the Regulatory Affairs CMC projects – authoring M2.3 and M3 of IMPDs/INDs and first MAAs/BLAs. Major Accountabilities: Lead as assigned large molecule projects in development providing regional strategic and operational Regulatory CMC expertise. Write and review the CMC sections of global and regional submission documents, IMPDs, INDs, new MAAs and BLAs etc. Manage CMC aspects of HA questions. What is there for you? Become part of a highly successful Biotechnology company that nurtures a team culture of mutual respect and support. Work on variety of projects in development, supporting drugs in Ph2 and Ph3. The location is in the M4 Corridor and is easily commutable by train from London and Reading and is easily accessible by car with company car parking on premises. Flexible working hours are available and you will be able to work from home for a couple of days per week once you have settled down . Experience needed: It is essential to have at least 5 years of Regulatory Affairs CMC experience authoring and reviewing of IMPDs for biological products as well as M3 for MAAs/BLAs. Experience of direct communication with the Health Authorities is required. We look forward to hearing from you. To Apply To apply , please send a full CV to CVAdvTalent.com , or alternatively, contact Oli Dimitrov on 44 (0)207 801 3388 or 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 team know our 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.