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RA Expert

Brussel

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2 Applied

Job description

  • Support for developing and implementing the regional regulatory strategy and submission plans for assigned projects/products
  • Identify supporting documdents required for regional submissions
  • Write regional and global documentation for submissions, in line with agreed global regulatory strategy, and within agreed timelines
  • Highlight anticipated and ongoing critical issues arising through the product life-cycle in a timely manner
  • Lead or provide support to all regulatory related interactions to facilitate and ensure satisfactory resolution of issues
  • Monitor and react as appropriate to changes in the regulatory environment in assigned regions
  • Lead or provide input to internal regulatory business initiatives and cross functional work streams

Benefits

  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Have you got what it takes?

Apply
  • At least 1 year of relevant experience in the pharmaceutical industry
  • Registration experience
  • Experience of direct communication and negotiation with regulatory agencies 
  • Fluency in English is a must. French or Dutch are a strong asset.
Reference number: 31729

Specifications

  • Home office
  • Nights
  • Weekends
  • Standby
  • Shifts
  • Employee
  • Freelance
Amandine Jansen
Talent Acquisition Lead Life Sciences
+32 491 15 34 75Mail me

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