Option Belgique Senior Regulatory Affairs Manager - want to work on a Blockbuster mAb?

Option Belgique Senior Regulatory Affairs Manager - want to work on a Blockbuster mAb? Note : This role is based in Brussels , Belgium and comes with a full relocation Are you an experienced Regulatory Affairs Manager and want to step up to an EU Liaison role to manage a set of line extensions through EU filing and review? After this you will rotate to a NME, currently in Ph2 . This role is working with an experienced Regulatory Director who has a lot to offer to help you on-board to the regulatory team successfully, and show you the ropes of the HQ. You will work closely with the Global Regulatory Lead , gaining exposure to the US and international environment, and being mentored on strategy, tactics and health authority negotiations . In return, you will have already assisted on MAAs or Line Extensions , on the one hand, or have developed PIPs, CTAs or prepared Scientific Advice, on the other, and now want to have full project ownership for your assigned indications. Although not mandatory, it is likely you have been 3.5 and 6 years in regulatory already (combined with your degree and industrial placements or research) and now want to be based in a global HQ for a company with around 12 NMEs in development, of which 4 are at or beginning Ph 3 studies so this is a busy time, in a pipeline rich R&D biopharmaceutical company . The Organization This is an R&D based biopharmaceutical company , with a strong pipeline, high % investment in R&D, successive years of growth, and led by industry renowned individuals in the commercial and development teams. The company offer the route to being a Global Regulatory Lead without having to work in the USA, and the regulatory team is a close knit, friendly, productive department. The role is led by a team regulatory director with many years’ experience, in leading ODD, MAA, and line extensions. You will join a team this team . The Benefits The role comes with full relocation support to Belgium , including an apartment, disturbance allowance, tax reduction package for non Belgiums , as well as a bonus , EU wide health insurance and ophthalmics as well as an extra legal pension. Applications are invited from EU Nationals, including UK Nationals, only . We can not support individuals without an EU Blue Card or EU Citizenship from any member state. ___________________________________________________________________________ To apply , please contact either myself, Theo , or my colleague Oli on 44 207 801 3388 or out of hours and weekends on 44 787 233 5879 - alternatively send a full CV to cvadvtalent.com and I will contact you by return. ___________________________________________________________________________ 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 team know our 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.