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Advanced Regulatory
,
London, Greater London
Regulatory Affairs Senior Manager CMC – Lead Submissions for NCEs, UK, M4 Corridor
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Salary: HASH(0x55809ca2c930) |
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Overview
We are seeking a Regulatory Affairs Snr Manager CMC to lead projects in development for small molecules in the South East of England. This is a permanent role leading submissions for NCEs in the EU and the rest of the world for an international pharmaceutical company. Our client is a fast-moving, global pharmaceutical company which is an R&D driven business that has over the years pushed the boundaries of what is possible in order to transform patients’ lives. This company invests heavily in cutting-edge scientific research, it supports is people and produces successful drugs that make real difference to people around the world. Main responsibilities: Lead as assigned small molecule projects in development providing regional strategic and operational Regulatory CMC expertise. Write and review global and regional Regulatory CMC submission documents, IMPDs, INDs, new MAAs and NDAs etc. Manage CMC aspects of Health Authority questions. What is there for you? Become part of a highly successful pharmaceutical 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 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 the role comes with a competitive salary and company bonus. Experience needed: It is essential to have at least 5 years of Regulatory Affairs CMC experience . Experience in successful authoring and compiling of IMPDs for originator products as well as MAA, Module 3 Experience of direct communication with the Health Authorities. Demonstrated leadership, communication skills and emotional intelligence. To Apply To apply , please send a full CV to OliAdvTalent.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 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.