Expiry Date: 19-02-2020
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Arrondissement de Paris
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.
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 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 for this role, please press the red “Apply for position” button, or contact either myself, Theo, or my colleague Oli on +44 207 801 3388 or out of hours and weekends on +44 787 233 5879 and we will contact you by return.
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