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Technical regulatory affairs - Belgium  

AIXIAL (company)


Posted on : 11 July 2017

Project Description

  • Our company is a company of the ALTEN GROUP, the European leader in engineering. 
  • Our company  is a Contract Research Organization (CRO) providing services to the life science industry for 10 years. 
  • Our mission is to support the key players of the pharmaceutical industry in France and Europe on different types of services: In-sourcing (CRO) and Outsourcing in environments as diverse as Bio metrics, Regulatory Affairs, Clinical Research, Pharmacovigilance and Quality Assurance.

Missions :
  • Writing CMC parts of regulatory variations 
  • Writing Module 2 of regulatory files derived from completed eCTD Modules 3 
  • Writing IMPDs as far as CMC information is concerned 
  • Writing Responses to Questions raised by Regulatory Authorities on CMC matters 
  • Update of internal tracking system linked to their CMC activities 
  • Involvement in internal initiatives for improvement of processes/ ways of working 

Education : Pharmacist or Master Degree or Ph.D. in the area of Pharmacy, Chemistry, Biology or Medicine
Experience  : 1-2 years RA experience in the pharmaceutical industry
  • Knowledge and understanding of regulatory legislation and guidelines related to CMC, procedural and administrative aspects. 
  • Previous experience in writing scientific / regulatory documents. 
  • Experience in preparation of cover letters, application forms, letters of intent would be a plus 
  • Team working skills, including optimal reporting and alerting capabilities 
  • Skills in the management of IT Tools ( Regulatory databasis, Documentum like tool) , Working English