Manager / Sr Manager Regulatory Affairs ** Biologicals, whole lifecycle ** Brussels, with Relocation

Reference: Oli10449

Expiry Date: 20-10-2019

Categories Clinical Research, Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

Manager / Sr Manager Regulatory Affairs ** Biologicals, whole lifecycle ** Brussels, with Relocation

We are seeking a Regulatory Affairs professional for a permanent role based in Brussels, Belgium. This role comes with competitive salary, decent bonus and relocation package including help to find a place to live.

This is a full lifecycle role graded Manager / Sr Manager, where you will work on a Clinical Line Extension and a PIP for a successful, high value, marketed biologic via CeP. You will support the GRL for the delivery of timely approvals and subsequently move on to NBE for a new MAA project.  

Our client is a growing multinational biopharmaceutical company with an impressive pipeline, that is primarily a research and development-based biopharmaceutical company that spends in excess of 20% on R&D. The company provides opportunities for individuals to excel in a team-based environment where the GRL career pathway would be open to you based on your achievements and merit. The company offers great training, support and the opportunity to work from home one or two days a week once you have finished the induction period.

I ask you to consider the following:

  • Do you have at least 4-5 years of Regulatory Affairs experience with biologicals?
  • Have you prepared INDs and / or CTAs?
  • Do you have experience with PIPs, Scientific Advice with the EMA, and / or Orphan Drug Designation experience?
  • Have you worked on MAAs or BLAs for biologicals?

If the answer to 2 or 3 of the above is Yes, then we would like to hear from you.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Theo Moore on +44 (0)20 7801 338 in full confidence if you would like to explore this role and opportunity further.

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