Expiry Date: 19-08-2020
Category Regulatory Affairs
Salary: On Application
Job Type: Full Time
Arrondissement de Paris
OPTION BELGIQUE *** Senior Regulatory Manager ** Lead 2 indications to NDA! Relo Offered!
Note: This role is based in Belgium and comes with a full relocation package!
You will be an existing Regulatory Manager or Regulatory Project Manager, and want to work on a NBE and take it through to Ph 3 design, readout, and final submission for a NBE which has great P2 data and multiple indications! You will work under an experienced Global Regulatory Leader who will mentor and coach you through the major regulatory milestones. This is what this role offers!
You will have worked in regulatory roles focusing on development, may be assisting a more experienced individual, or you will have supported NDAs or new clinical line extensions and now want more accountability for your own filings without overextending, as you will have both the Global Regulatory Leader and your Team Director, to support you.
You will want to work in a company where regulatory is a well-functioning machine, has a seat at the table for strategic discussions, and where regulatory works closely with OR/PRA, Clin Science, PhV, and the major project team members to deliver rapid submissions, for a molecule with adaptive or innovative development and filing pathways.
This is an R&D-based biologicals pharmaceutical company, with a great deal of experience and track record in their chosen therapeutic areas. The role is being hired by an individual with a strong track record in NDA/MAA filings and is regarded as a trustworthy and decent people manager. They have a strong pipeline with a number of late phase programmes, and are on the verge of major expansion, from new submissions, in the next 2 years.
The Package & Benefits
This role is based in Belgium and comes with full relocation, including disturbance allowances, temporary high quality apartment, as well as a tax reduction package (for non-Belgium nationals), as well as a performance bonus, decent annual salary, and full healthcare with EU coverage. There is also a extra-legal pension.
Make An Application!
To apply for this role, please press the red “Apply for position” button, or contact either myself, Theo, or my colleague Oli on +44 207 801 3388 or out of hours and weekends on +44 787 233 5879 and we will contact you by return.
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