Job Description

Global Regulatory Leader - Regulatory Director - LEs on a Blockbuster!

Please note this role is based in Brussels, Belgium and is open to any EU member state applicants as it comes with full support for relocation: there are a package of measures including private schooling for non-Dutch / French-speakers, plus if you have an existing stock plan they will consider buyouts for compelling candidates, and support for relocation post-Covid, until then the successful candidate will work from home in their original country!

On Covid-19: My client offers Digital Hiring and On-Boarding process using Video Conferencing and the successful candidate will be inducted and trained remotely. During the next period, new hires will be allowed to work from home full-time, until such a time occurs when normal working returns and travel restrictions are stopped!

About this Opportunity

This is a role with a global mid-sized biopharma company with four disease areas with nearly 100 years history and track record of bringing new medicines to market. Not a top 10 pharma global companies, but is fast moving/high-growth, and much more lean and agile than larger companies and has driven sustainable growth in all the core regions:-

• You have EU or EU & international regulatory experience (IMPDs, NDAs, MAAs, Line Extensions, PiPs, Post-approval submissions etc) and want to move into a GRL position and be the single accountable person for the global including US?
• You feel you are ready to step up from either an EU RL role to a GRL one, or find the Director grade attractive and believe you are ready for this!
• You want to work on a Blockbuster drug with sales >EUR 1.5B with expected continued growth and lead the final execution of their pending line extensions and new clinical indications worldwide?
• Do you want to be the GRL in a project team in a company where there is no regulatory therapy head as such and you and the GP team are the final arbitrators in product and regulatory strategy and planning?
• Do you want to join an organization that invests in its people and where the GRL sits with development/medical/commercial counterparts and where you will gain exposure to non- regulatory commercial and clinical team objectives?

Your Background & Experience

• You have a regulatory track record assisting and leading on MAA, Line extensions and US equivalents (SNA/sNDAs)?
• You have gained exposure on the global regulatory development and lifecycle environment in the last 7 years by working with your US counterpart and now feel ready to step up to the GRL role?
• You have experience working in a cross functional environment with a demonstrated competence in people management together with a knowledge of interacting with and negotiating with health authorities, including milestone meetings.

Package & Benefits

• Do you want to relocate to Brussels with full coverage including disturbance allowances, temporary high-quality apartment, as well as a tax reduction package (for non-Belgium nationals) together with a performance bonus, competitive annual salary, and full healthcare with EU coverage? The role comes with a fully expensed car and petrol card for personal and company use!
  
  

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Matt on +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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