GRL Regulatory Director - LEs on a Blockbuster! (Code DK)

Reference: OD170420C

Expiry Date: 17-08-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Denmark

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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 Octavian or Matt on +44 (0)207 801 3387 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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