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Advanced Regulatory
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London, Greater London
Regulatory Affairs CMC, Global Regulatory Leader - EU, US and RoW
Overview
Regulatory Affairs CMC, Global Regulatory Leader, at Associate Director level - EU, US and RoW - Strategic leadership role Location : M4 Corridor, easily commutable from London, Maidenhead, Slough, High Wycombe, Uxbridge, Reading, Windsor and the surrounding counties. ADV Talent Partners are recruiting for a Global Regulatory Leader to provide Global product leadership, setting the CMC regulatory strategy and driving it through to implementation with regular interactions and negotiations with Health Authorities, working in a matrix environment within a multi-disciplinary and multicultural organization. Our client is a growing pharmaceutical company that is at the forefront of innovation with a friendly cultural and a strong regulatory team that really operates as a team, supporting each other when there are submissions or peaks in workload. Decisions are yours to make, as there is a high level of empowerment and autonomy within the team. You need to be independent, calm, cool and collective, prepared to give guidance to team members and other technical teams. This is a permanent role based in Brussels, easily commutable via public transport or via car. The role comes with a competitive salary, short and long-term incentive programs as well as car allowance, some flexibility to work from home 2-3 days a week and a lucrative stock options package. Our client is searching for an experienced Regulatory Affairs CMC professional (at Associate Director level) who enjoys being technical and hands-on, who is happy leading and managing their own projects, authoring IMPDs, working on PIPS, taking the lead for products in early or late development, giving strategic input, providing input and sometimes leading Scientific advice meetings and also supporting MAA/NDA’s and global expansion projects. Ideally you will be self-motivated, strategic and pragmatic, focused on internal and external customer satisfaction. In return you will receive great job satisfaction, wonderful work-life balance and the opportunity to work in a friendly, transparent and dynamic organisation. Experience needed: Regulatory Affairs CMC focused product development and lifecycle management experience for regulatory strategy for either the EU or US and/or emerging markets. You will need to have a number of regulatory achievements around defining and implementing regulatory strategies for development compounds and marketed products in EU, US and/or International markets. To Apply To apply , please send a full CV to TheoAdvTalent.com , or alternatively, contact Theo Moore on 44 (0)207 801 3384 or Oli Dimitrov on 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.