EUROPE ** Senior Regulatory Manager ** Have you worked on a line extension and now want to work on a new MAA ** With Relocation

Reference: MG10407A

Expiry Date: 07-11-2019

Category Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Belgium

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Job Description

 

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:-

  • Preparation of regulatory CTA submissions, Scientific Advice or PIPs
  • Preparation and / or filing of Line Extension New Indications
  • Early Phase regulatory work, whether for a CRO or PharmaCo
  • Regulatory coordination and management of Day queries or FUMs (follow up measures) even if you joined the project just post submission.

In return, my client will pay for a relocation including temporary housing and a settling-in allowance, plus a strong package including bonus, plus 48 days off a year and a top level health insurance package.

 

To Apply!

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 Matt Greig, in the London office on +44 (0)20 7801 3384, or at any time during evenings on +44 (0)7918679405.

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We match professional candidates to the best permanent, contract and interim roles in the market.

We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.

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.

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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