EU Regulatory Lead / Liaison? Next Step Global Regulatory Lead (NBEs)

Advanced Regulatory ,
London, Greater London
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Overview

EU Regulatory Lead / Liaison? Next Step Global Regulatory Lead (NBEs) This role is based in the UK nr West London, Middlesex, Berks, Bucks and western Hertfordshire. My team and I are excited to bring to your attention this brilliant opportunity to take the position of a Global Regulatory Leader in a development program for an immunology NBE for patients with highly unmet and critical needs. Consider:- Are you a EU Regulatory Affairs Lead who is looking for your 1 st global role (incl. US)? Are you ready to lead a Phase 3 development program world-wide? Do you have a strong track record in Europe with exposure to the US or China regulatory pathways? Have you worked on biologicals or have a bio-related higher degree? If you find yourself saying YES, then definitely this vacancy is for you The Opportunity You will be provided with the unique opportunity because you can use your track record in EU development and regulatory filings to step upto the global regulatory strategy leading role. In this role you will be responsible for shaping and delivering a global regulatory strategy for your NBE, and will manage the regulatory sub-team, in matrix, from the Phase 3 CD all the way to marketing approvals on for core markets, including the USA, Europe, and international majors. The Company A respectful organization with international success that harbors some of the brightest people in the industry; growing steadily with a stable of high performing products and 3 distinct therapy areas The Team The Global Project Team has strong experts with the disease and molecule knowledge, and are based in the UK and mainland Europe; you will report to the PL for this role You should definitely send through your CV if you have: Worked at least 7 years in Regulatory Affairs ideally with strong clinical phases experiences and working with biological products Solid experience in interactions with the EMA and exposure to the US regulatory framework Have previously led in matrix the regulatory sub-team albeit in Europe Exposure to other major Health Authorities such as Japan, China, Canada, ANZ Successful submissions track record Great communication skills I look forward to receiving your resume along with your mobile number so I can share more about the vacancy and my client To Apply To apply , please send a full CV to DavidAdvTalent.com , or alternatively, contact David on 44 (0)207 801 3385. 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.

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