OPTION BELGIQUE Senior Regulatory Manager Lead 2 indications to NDA Relo Offered

Advanced Regulatory ,
Leominster, Herefordshire
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Overview

OPTION BELGIQUE Senior Regulatory Manager Lead 2 indications to NDA Relo Offered The Opportunity 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. The Company 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. About You Minimum experience of preparing Ph 3 CTAs (not CTA ops, more build, review, support for inputting into Clinical Protocol) combined with ODDs or having assisted on a New Indication Line Extension; preparation of Scientific Advice Meetings, or PIPs PharmD or BSc/MSc or equivalent in life sciences; good communication and coordination skills Ability to influence stakeholders by using regulatory intelligence and data driven communication in a friendly and useful way A willingness to take part in coordinated multi-indication development programmes , by working with your colleagues who are managing the other indications Make An Application ___________________________________________________________________________ To apply , please contact in the first instance either myself, Theo , or my colleague Oli on 44 207 801 3388 or out of hours and weekends on 44 787 233 5879 - alternatively send a full CV to cvadvtalent.com and I will contact you by return. ___________________________________________________________________________ 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 44 (0)207 801 3380 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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