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Regulatory Scientist - Belgium  

UCB (company)


Posted on : 15 April 2017

Project Description

  • We put our heart, soul and skills into making a difference for people living with severe disease.
  •  Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?  
  • To strengthen our Regulatory Science: Neurology division,we are looking to fill the position of:  Regulatory Scientist.  

As an 'ethiborative' person and Regulatory Scientist you like to work in an environment where you can:    
  • Serve as primary regional point of contact for the GRL   
  • Develops / implements the regional regulatory strategy plan   

As an 'ethiborative' person and Regulatory Scientist you will contribute by:    
  • Lead the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.   
  • Deliver regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.   
  • Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice   
  • Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.   
  • Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL.   

For this position you’ll need the following education, experience and skills:    
  • A BSc/ Master’s degree in a relevant Life Sciences discipline   
  • At least 5 years’ experience (min 5-10 years for the Regulatory Lead) in pharmaceutical regulatory affairs working with cross-functional and international teams   
  • Knowledge and experience of EU regulatory procedures and legislation related to drug development, product registration, line extension and/or license maintenance.   
  • Proven successful contribution to delivering regulatory approvals (Regulatory Lead).   

Job Segment:  Scientific, Neurology, Regulatory Affairs, Scientist, Law, Engineering, Healthcare, Legal, Science