Regulatory Affairs, CMC Global Regulatory Leader, Biologics - Brussels

Reference: OLI10571

Expiry Date: 24-10-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description

Regulatory Affairs, CMC Global Regulatory Leader, Biologics - Brussels

Location: Brussels, easily commutable via car or public transport.

Do you want to take the lead for global biological development projects?

This is a rare and unique role where you can take the lead for Global registrations for Biological products in mid and late stage development through to registration and Global expansion!

My client is a Global Biotechnology company  with a pipeline of nearly 20 indications in development, with 5 major product registrations planned in the next 2-3 years. They are recruiting for a bright and ambitious Regulatory CMC professional to take the lead on developing global regulatory CMC strategies for mAbs in development guiding them through both EU and US registrations.

This highly efficient and extremely successful medium sized Biotechnology company has developed a hugely impressive pipeline of large molecule biologicals in mid and late stage of development. There are a number of potential blockbusters due for filling in the EU and USA over the next 1-3 years. As a result my client is now seeking a highly experienced CMC professional with a biological background gained through experience in either EU or US markets to take the lead in setting global strategies and coordinating complex submissions for the US, Europe and major markets.

This is a highly visible role that requires strong levels of leadership for multiple cross-functional project teams and strong organizational and analytical skills to drive and provide strategic / operational regulatory CMC direction. 

Your duties will include responsibility for leading global CMC regulatory strategy for biologic development of projects and marketed products. This will include HA meetings and negotiations for FDA and EMA. You will also lead and matrix manage for internal & external teams on assigned projects for the preparation and review of IND/IMPDs, NDA/BLAs and EU and International MAAs.

With this excellent role comes an excellent package which includes: a high level basic salary, bonus, car allowance, full re-location package to beautiful Lausanne with expectations that you will take the lead for Global projects.

You must have knowledge of working within European Regulatory Affairs specifically as applied to biotechnology products.

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact Oli Dimitrov on +44 (0)207 801 3388 or Theo Moore on +44 (0)207 801 3384 in full confidence to receive more details on this role or to hear about other available opportunities in Regulatory Affairs.

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