M4 CORRIDOR Regulatory Programme Manager EU and GRL Career Pathway NMEs and Lifecycle combined Pure
M4 CORRIDOR *** Regulatory Programme Manager *** EU and GRL Career Pathway *** NMEs and Lifecycle combined *** Pure mAbs role __________________________________________________________________________________________ This role will appeal to individuals working in US companies where decision making is sometimes held back in the US, and you want to be in a company where 70% of ALL decisions are made in the EU. This role can be based in the M4 Corridor / West of London, Middlesex & Berks areas, come with an attractive salary, bonus, and a great deal of opportunity to grow. This company has a track record of developing individuals from Manager and Senior to the Global Regulatory Lead level. __________________________________________________________________________________________ This client is an expanding bio-pharmaceutical company with new products coming to market, and major new NMEs coming out of Ph 2B in to Ph 3, requiring new headcount, and an expansion of their regulatory development teams. These roles are at Senior Regulatory Manager level, and will appeal to the following individuals:- Aspiring, hard-working, willing to get stuck in, you could be a looking for your next career role having developed in your current role, and now want a new challenge You see yourself at Manager or Senior Manager level: you have already co-led your own projects for NMEs in Ph 2/3 or filed MAAs or Line Extensions You will have authored Brochures for EMA SA / EOP2 and co-/led Scientific Advice meetings with the EMA or national HAs; you will have devised and developed regional regulatory strategy documents and plans Offer a strong combination of the scientific background (MSc or PhD ideally, BSc also considered) coupled with regulatory and business understanding, able to translate clinical data and clinical science to develop narratives in to RA strategies and dossiers that regulators can understand Want progressive, step wise development and want to be a GRL in the future, without having to move to Switzerland or the USA; in return are willing to be flexible, work across multiple products / projects Fundamentally you believe yourself to be a Strategic Thinker, wanting to develop in to the GRL role based on your merit and performance. Although this is just a guide, you will have 4-7 years EU or international plus EU regulatory experience gained on NMEs or major new indication programmes. We have more than one role, so can accommodate more than one background type because this company wants diversity in their teams. __________________________________________________________________________________________ If you wish to apply for this role, please send your CV with a covering note to firstname.lastname@example.org 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 +44 (0)20 7801 3380. __________________________________________________________________________________________ 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 www.advregulatory.com. 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: Senior Regulatory Manager jobs, Sr RA Manager Jobs, Senior RA Manager Jobs, Regulatory Affairs Vacacnies, Reg Affairs, RA Jobs, Regulatory jobs in Bucks, Regulatory jobs in London, Regulatory jobs in Berkshire. To Apply : Please send a full CV in confidence to email@example.com.