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Regulatory Affairs Liason - Belgium  

Galapagos (company)


Posted on : 05 June 2017

Project Description

  • The Regulatory Affairs Liaison (specialty CMC) is responsible for managing the day-to-day support activities to obtain and maintain regulatory approvals for company’s  products, with primary focus on the overall regulatory aspects of clinical trial submissions and a specialty in CMC documentation.
  •  The Regulatory Affairs Liason (CMC) is a standing member of assigned clinical working groups and is the primary regulatory liaison with the CMC department.   

Principal Accountabilities  
  • Coordination, preparation, submission, maintenance, and compliance of regulatory aspects in clinical trial applications, with a specialty in quality IMP documentation, in close collaboration with the CMC department and the assigned Regulatory Lead.
  • Assist in the preparation and compilation of scientific regulatory dossiers and briefing packages (e.g. scientific advice, eCTD Module 3, quality IMPD).
  • Regulatory intelligence: Stay current with changes in regulatory CMC requirements and inform and advise the internal organisation and the CMC subteam. 
  • Assist in the preparation of regulatory guidance summaries to support and facilitate strategic decision-making.
  • Records Retention: Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
  • Assist in the compilation and implementation of defined procedural documents and processes for the department.  

University degree in health sciences, pharmacy, biological science, chemistry or related field.  

  • At minimum 5 years of relevant experience in CMC regulatory affairs in a range of projects, and including writing of CMC documents. 
  • Previous experience in the development of fixed-dose combination products is an advantage.   

General Skills 
  • Demonstrated attitude of reliability and attention to detail. 
  • Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success. 
  • Professional attitude towards external and internal contacts.
  •  In addition, data gathering, problem solving and analytical thinking skills are highly desirable.   
  • Communication Skills 
  • Strong verbal and written communicator in English language, multilingual is an asset.