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Regulatory Affairs Manager / Snr Manager CMC Biologicals role - Join a Nr ref.: /JOBS.pl Regulatory Affairs Manager / Snr Manager - CMC Biologicals role - Join a global biotech company with a great portfolio - Brussels Location: Brussels, with options to work 2 days a week from home. Advanced Search and Selection have a new Regulatory Affairs Manager / Snr Manager role for a global biotech company. The roles are varied and cover the strategic execution of European Regulatory CMC strategies of projects/products through all stages of development and through to registration and lifecycle - A full Project lifecycle role…!!! This organisation has a fantastic portfolio of products in development so you will have a great platform from which to take the lead in your projects. Based in Brussels, Belgium you will be working from the EU headquarters in a role that covers all major regions within the EMEA. This will be an EU (into Global) role and the pipeline for Biologicals in all stages of development (from PI to PIII and registration) and the snr management team are very highly rated within the industry and have a reputation for allowing others to take real project ownership whilst you will still be pushed to develop your technical, strategic and operational expertise. The Role: You will be responsible for Provision of CMC regulatory advice to project teams; through all stages of development Provide CMC expertise and guidance for Bio ( through early phases, late phases, MAA preparations, review and lifecycle management EMEA markets Take responsibility for authoring, reviewing and responding to questions on CMC aspects of IMPDs, PIPs, Module 3 leafs for MAA and variation submissions and CMC scientific advice; Operate as the EU CMC-RA representative on global regulatory subteams, CMC development teams and RA/QA liaison team advising on regulatory CMC issues; There is an excellent salary available for this role and this position also offers an attractive salary, strongf Bonus, and a Full- Re-location Package. Ideally you will have at least 4 years' experience in CMC biologicals with a background in Monoclonal antibodies, vaccines, Advanced Therapies, Proteins or Biosimilars. _____________________________________________________________________________________________ If you wish to apply for this role, please send your CV with a covering note to or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on (0). _____________________________________________________________________________________________ About Advanced Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs. We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at . We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter. Keywords / Key words: Regulatory, Regulatory Affairs, Reg Affairs, RA, Regulatory jobs, RA jobs, Regulatory Affairs Jobs, CMC, Bio, Biotechnology, IMPD, IMD, Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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