Expiry Date: 07-11-2019
Category Regulatory Affairs
Job Type: Full Time
Location: Brussels, Belgium
We are pleased to present you this role for a major bio-pharmaceutical company, where both the ideas of the GRL career pathway and working on a new MAA are part of this opportunity. You will be joining a successful company in a smaller team to focus on filing a MAA with multiple indications, a mAb, which is currently at the End of Phase 2 / Phase 3 where you will directly work with the GRL who is highly experienced and much liked.
So you will want to work in an organization where the GRL career pathway is open to you, but to get there you want to consolidate your experiences and build upon these by working on taking a NBE from Phase 3 into filing and review. So this will include preparing CTAs for submissions through CROs and the affiliates, preparing Scientific Advice / Pre Subs Meetings and Brochure packs for different indications and, for PIPs. After this, the team will work together to prepare the MAA (in a company where the CMC is done by another team).
The role can be graded Senior Manager / Manager and you will be part of a team where most of the GRLs and Team Managers started in a near identical roles, so they have managed to grow, and so will you, because the environment lends itself to sharing know-how and working collaboratively, where merit is rewarded.
You will have 2 of the following to be able to apply for this role:-
In return, my client offers a strong package including bonus, plus extra-legal days, and a top level health insurance package.
To apply for this role, please register on this web site. My team and I would welcome a phone call in private if you would like to explore this role and opportunity, then please contact either myself, Theo Moore, or my colleague Oli Dimitrov, on +44(0)2078013384 or +44(0)2078013388, or at any time during evenings on +44 (0)7918679405.
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