NEW REGULATORY ROLE ** Sr / Regulatory Manager ** NBE role ** Based Brussels with Relocationith Relo

Location
Brussels, Belgium with Relocation
Salary
On Application
Posted
10 Oct 2019
Closes
09 Nov 2019
Ref
MG/050719A R6
Contact
Theo Moore
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

NEW REGULATORY ROLE ** Sr / Regulatory Manager ** NBE role ** Based Brussels with Relocation

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!

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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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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

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All applications are kept in confidence and we invite applications from all members of the Academic, Research & Development based bio-/pharmaceutical community.

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