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Global Regulatory Lead (Belgium)

Global Regulatory Lead (Belgium)

UCBAnderlecht, Brussels, Belgium
Il y a 23 jours
Description de poste

Make your mark for patients

We are looking for a Global Regulatory Lead to join us in our Global Regulatory Affairs team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta or Raleigh (US) offices.

About the role

The Global Regulatory Affairs Leader provides regulatory leadership tailored to the assigned candidate asset or brand. The Global Regulatory Lead leads the global Regulatory Strategy Team for assigned projects and is a key member of the project team.

Who you’ll work with

The role reports into the Global Regulatory Strategy Team Lead

What you’ll do

  • Serve as the Regulatory point of contact on the assigned projects with senior management and / or at other internal meetings providing the agreed global regulatory strategic recommendations, aligned timelines and risk / mitigation assessment for key projects.
  • Ensures the Global Regulatory position / strategy is agreed and aligned functionally (ie within Global Regulatory Affairs, Regulatory Stakeholder Leadership Team) and on the respective project teams in view of relevant governance meetings where agreed global regulatory functional views are presented.
  • Accountable for the timely development and implementation of the global regulatory strategy and plan(s). These plans are based on an agreed Target Patient Value Profile designed to meet the needs of the business and patients for assigned projects (to deliver timely product milestones (e.g. Health Authority meetings, new indications, etc.), ultimately leading to approval with a viable label meeting the needs of patients and the business.
  • Accountable for delivering all regulatory milestones related to the assigned projects including assessment of the approvability of the program submissions together with global regulatory risk mitigation measures (supported by the regions as appropriate).
  • Accountable for the review of global / regional submission key documents (as applicable) and ensuring global alignment of key messages in line with Asset Team objectives.

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

  • Bachelor’s degree required
  • 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.
  • Knowledgeable in the area of digital and AI technologies that enhance overall drug development and regulatory strategies

    • If you are interested to learn more about R&D within UCB, please find more information here .

    RANDATUCB

    Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

    Créer une alerte emploi pour cette recherche

    Belgium • Anderlecht, Brussels, Belgium