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Regulatory Business Analyst - Belgium  

AIXIAL (company)


Posted on : 11 July 2017

Project Description

The Regulatory Business Analyst will be acting as project manager for the driving of specific processes and activities as risks, capa, audit coordination in collaboration with owners and stakeholders. He/She will also participate to the development/maintenance of the related documentation and KPI.
The Position Holder will need to dissect various processes / ways of working applied within Global Regulatory Affairs and assess the most logical and efficiency way in order to meet business and compliance needs, taking into account performance.
  • Ensure that risks and quality processes and activities within Global Regulatory Affairs are adequately done, supported by appropriated and robust processes and that these processes (and/or associated procedural documents) clearly reflect the roles and responsibilities of the various groups within Global Regulatory Affairs; 
  • Manage and facilitate input from Global Regulatory Affairs stakeholders as well as external key stakeholders. 
  • Develop KPIs to assess the efficiency of the new processes/interfaces. 

Education : University level (Science or Management background) or equivalent by experience.
Experience  : 2-5 years in the Pharmaceutical Industry in RA department or Project Management Environment
  • Knowledge of regulatory affairs and a variety of regulatory submissions and processes 
  • Project management experience 
  • Risks management experience is a plus 
  • Quality Experience is a plus 
  • Coordination of audit and Capa follow up is a plus 
  • Business Continuity Plan experience is a plus 
  • Six Sigma certification (green belt or black belt) is a plus 

  • Good communication, presentation and influencing skills 
  • Fluent in English (written and oral) 
  • Good cultural awareness and negotiating with customer competencies 
  • Logical/process oriented approach 
  • Ability to conduct a stakeholder analysis 
  • Team player 
  • Indepent interaction, influence and leadership with teams to ensure teams keep on track and