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Advanced Regulatory
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London, Greater London
Senior Manager Regulatory Affairs CMC, lead and support EU submissions for NCEs
Overview
We are hiring for a Senior Manager Regulatory Affairs CMC for an international Biopharmaceutical company. Location: London, M4 Corridor. Our client is an R&D driven Biopharmaceutical company with an impressive pipeline of product as well as a number of blockbusters. This is a top biopharmaceutical company that is now expanding their Regulatory CMC teams both in the UK and in the US. This role is based in London and will support small molecules coming up in development for EU submissions. Our client has been highly successful over the past decade and their growth is set to continue for the next 10 years. They have put themselves in this position by investing heavily in cutting-edge scientific research and producing successful drugs that are making a real deference to patients across the world. This company invests in its people, and in this role you will be supported by an experienced Regulatory Affairs CMC Director. Responsibilities In this role you will provide Regulatory CMC expertise and will be responsible for assigned projects, supporting and leading submissions in the EU for products in development. Responsibilities will include writing IMPDs for specific molecules, new MAAs as well as having an input in the overall Regulatory CMC strategy. You will be the primary contact for the Health Authorities for assigned region/s – mainly the EU, Middle East and North Africa or Asia – Pacific. What we need We need an experienced regulatory affairs professional with over 5 years’ relevant experience in Regulatory Affairs CMC. You would have experience in successful authoring and contribution to timely delivery of submission documents - CMC sections of IMPDs, MAAs etc. Experience working on late stage development projects. Direct communication and negotiation with Regulatory Agencies on CMC matters as well as experience managing all AH interactions for assigned region/s. Benefits This role will give you the opportunity to become an integral part of a growing Regulatory Affairs CMC team serving as a Product Lead. You will receive real support from talented and highly experienced Regulatory CMC Director helping you on the career path to become an AD in the future. The salary package is very competitive and includes a bonus (10%), company benefits as well as extensive company benefits. The location is easily commutable by public transport from London, Berkshire and Reading. There is car parking for those who drive. ___________________________________________________________________________ To apply , please contact Oli Dimitrov on 44 (0)207 801 3388 or Theo Moore on 44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs. ___________________________________________________________________________ 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.