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Regulatory Affairs Senior Specialist Woluwe-Saint-Lambert Belgium,  

ASIT Biotech (company)

Posted on : 01 December 2016

Project Description

In order to face the development of our activities, we are currently seeking a Regulatory Affairs Senior Specialist to support the Regulatory Affairs activities related to the development of new technology based allergy immunotherapy products.

Main responsibilities will include: 

  • Coordinate, prepare and follow-up the submission of regulatory documents for national or international clinical studies.  
  • Prepare or maintain technical files as necessary to obtain and sustain product approvals. 
  • Interact with  regulatory  agencies  regarding  pre-submission  strategies,  potential regulatory  pathways,  compliance  test  requirements,  or  clarification  and  follow-up  of submissions under review 
  • Provide  regulatory  advice  to  project  teams  (compile key regulatory  documentation, provide interpretive assistance) 
  • Participate to definition of regulatory strategy 
  • Provide  technical  review  of  data  or  reports  that  will  be  incorporated  into  regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.  
  • Draft product labelling, instruction leaflets and packaging.  
  • Participate  in  internal  or  external  audits,  inspections  and  provide  post-inspection follow-up information as requested 
  • Write or update standard operating procedures, work instructions, and policies.  

Requirements and competencies:

  • Scientific degree in life sciences or pharmacy 
  • Minimum 5 years of experience in the field of Regulatory Affairs 
  • Solid knowledge of ICH guidelines, EU regulations required for Regulatory submissions and Good Clinical Practice (GCP) guidelines  
  • Strong organizational and communication skills (oral and written) 
  • Analytic capacity, attention to details, meticulous 
  • Solid writing and editorial skills 
  • Team player, strong interpersonal skills 
  • Able to work independently within your area of responsibilities 
  • Demonstrated ability to deliver results to the appropriate quality and timeline  

We offer  

To join a company with a very high growth potential, to integrate a very competent and motivated team, to  collaborate  to  the  development  of  innovative  products  in  a  very  dynamic environment, attractive salary and benefit package. 

About Us:

We are a  Belgian  clinical  stage  biopharmaceutical  company  focused  on  the development  and  future commercialisation  of  a  range  of  breakthrough  immunotherapy products for the treatment of allergies. We currently have a headcount of 22 staff members, located at our headquarters in and in the laboratory.  


Woluwe-Saint-Lambert, Brussels, Belgium

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