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Global Regulatory Lead

Location: 

Anderlecht, Brussels, Belgium

Job Function:  Regulatory Affairs
Job ID:  67720

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Global Regulatory Leader

 

To strengthen our Global Regulatory Affairs department based in our Headquarters based in Brussles, Belgium are looking for a talented individual to fill the position of: Global Regulatory Leader.
 

As a Global Regulatory Leader, you will be accountable for the global regulatory strategy and oversight of implementation/execution in alignment with the Regional Regulatory Leads and other RST members.

 

You like to work in an environment where you can:

  • Provided regulatory leadership to assigned Mission and/or asset. 
  • Lead the global Regulatory Strategic Team (RST) for assigned projects.
  • Leading and coordinating Mission regulatory budget and Practice resource discussions on behalf of the PVU and the GRA practice for assigned projects.

 

You will contribute by:

  • Being Regulatory point of contact on the assigned Mission/PST with senior management providing the agreed global regulatory strategic recommendations and risk assessment for key projects.
  • Being accountable for the timely development and implementation of the global regulatory strategy and plan(s) designed to meet the needs of the business and patients for assigned Missions and/or projects.
  • Participating and contributing to PVU global strategic initiatives and tactical plans related to the gathering and analyses of customer insights in the field and the consequential design/adaptation of Mission/PST business strategies.
  • Chairing the global Regulatory Strategic Team meeting for the Mission and/or product, to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
  • Leading and coordinating, on behalf of the Mission/PST, discussions around Practice resource needs and Mission regulatory budget to deliver Mission/PST and agreed upon GRA objectives

 

Interested? For this position you’ll need the following education, experience and skills:

  • Several years’ experience in pharmaceutical regulatory affairs.
  • Knowledge of global regulatory procedures and legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension and license maintenance. Global regulatory experience is a plus.
  • Global and integrated cross-functional view into pharmaceutical project management and drug development/approval and commercialization. Ability to appreciate multiple cross-functional elements contributing within drug development and ability to develop an adequate and coherent supportive global/local regulatory strategy.
  • Good track record of (contributing to) delivering regulatory approvals.
  • Direct experience in interacting with and negotiating with health authorities, including milestone meetings.
  • Knowledge of scientific foundation, enough to understand all aspects of regulatory issues in an authoritative way and discuss with technical experts.

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

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Apply now »