Expiry Date: 03-01-2020
Categories Biotech, Regulatory Affairs
Job Type: Full Time
Senior Regulatory Manager ** Have Line Extensions or Orphans? Work on a NBE MAA 6+ indications!
This role is open to anyone from the EU or the UK, and is based in Brussels, Belgium. The company offers a full relocation and support package including temporary housing, settling-in allowance and for non-Belgium’s, a tax reduction package. This role can be graded as Manager or Senior Manager and comes with a bonus, health insurance, as well as 38 days off a year plus national holidays.
About this Vacancy
This role is based in their global HQ, so there is plenty of opportunity to gain exposure and then experience to global regulatory strategy and decision-making. The line manager is experienced and a warm person, working for this well-known, R&D based bio-pharmaceutical organization, with a strong pipeline of NMEs, and on this 1 NBE in particular, for which we are hiring. You will work in a small dedicated team, preparing an adaptive and complex set of filings, including the first filing MAA under Centralised Procedure, as well as Line Extensions and before that a number of ODDs.
The company are going to be able to file the ODDs fairly quickly so you will gain successive filing experience in time, but initially will be supporting the EU Liaison bring all the programmes on line.
Additionally, the company offer the GRL and Team Manager pathway, so if your heart is in global strategy or eventually managing regulatory people, they can accommodate your long-term development objectives.
Qualification & Experience
My client will consider anyone who is already at the Sr Regulatory Specialist or Regulatory Manager or an existing Senior RA Manager (if you want to work on NBE pre-submission), who wants to learn and be part of a busy programme. You will either have assisted or led on a MAA or Line Extensions or have prepared and submitted ODDs. Additionally experience with preparing Scientific Advice brochures, PIPS / PSPs, annual safety updates, CTA updates and dossier reviews, would be very useful. If you have worked in a regulatory consulting team of a CRO, and have gained some or all of the above, you are also invited to apply!
To apply for this role, please contact Theo Moore or Oli Dimitrov on +44 (0)207 801 3384 or +44 (0)207 801 3388, or send your full CV in confidence to CV@AdvTalent.com.
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