Expiry Date: 26-12-2020
Category Regulatory Affairs
Job Type: Full Time
Regulatory Affairs Director – Global development role for Biologicals – Brussels
Are you looking for a role that will utilise your vast EU registrations experience but also give you US responsibility as a GRL? My client has multiple indications in different stages of development and is recruiting for EU leaders who want to become GRL’s.
Location: Brussels, but with great flexibility around home working, post COVID
We are now hiring for an experienced regulatory strategist and regulatory project manager. You will have already established your career level as a Regulatory Liaison or RA Leader, and now want to establish yourself on the global strategy level where you are responsible for the global strategy document, and for co-defining with the partners, the clinical development and regulatory pathway for NMEs in early and/or late phase development. This group is therapeutically aligned and they have a broad range of indications in different stages of development.
This role is not for someone who wants to do line extension filing after line extension filing (call me if you want this as I have other roles), because this role is more focused on developing the value for the molecule, identifying potentials for speedier or parallel development, adaptive or innovative pathways for both the EU and US regions …. and more! You will you use your experience and expertise to shape the direction of your indications globally, in matrix teams that also have profit and loss/financial reasonability for their proposed programmes.
Personality wise, you will have a friendly and engaging personality, willing to work with senior leaders from market access, brand marketing, clinical and quality to generate new ideas and shape existing ones. You will be a team player, but know how to influence individuals to steer programmes, in a company which has a strong matrix.
Experience-wise, US exposure is useful, as you can imagine, but the requirement is you have some actual strong late phase development and / or extensive MAA experience and understand how regulatory can lever their know-how to drive drug development, initiate and manage useful health authority interactions, and prime the molecule for commercialization in Phase 3. You could have a big voice on the POC decisions at end of Ph 2 but for sure you will lead the role out across the EU, US, China & Japan via your global matrix team(s).
We have options on grade, so you can be interested in either an Associate Director or Director grade.
To apply for this role, please press the red “Apply for position” button, or contact Theo Moore or Matt Greig on +44 (0)207 801 3384 or +44 (0)207 801 3386 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.
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