ABOUT THIS ROLE

• Lead and coordinate all Regulatory Intelligence activities, including research on regulatory updates, communication to stakeholders, and tracking the impact and implementation actions.
  
• Act as the point person for regulatory intelligence related consultancy.
  
• Assist the Parexel Quality group in the preparation for and follow-up of internal/external audits and inspections, as needed and relevant to Regulatory Intelligence Activities.
  
• Maintain the Regulatory Intelligence Share Point and filing areas.
  
• Provide technical knowledge where appropriate.
  
• Collaborate with Parexel Quality to develop and update quality/process documents, tools, and templates in line with regulatory intelligence activities.
  
• Generate metrics on Regulatory Intelligence Activities.
  
• Contribute to the metrics provided to Senior Management.
  
• Complete assigned goals for key QMS elements, with a special focus on Knowledge Management/Regulatory intelligence activities and oversight.
  
• Undertake other duties as assigned.
  

• Educated to degree level (technology, biological science, pharmacy, or other health-related discipline preferred) or equivalent qualification or clinical research experience.
  
• Experience in Quality Assurance, Quality Management, Regulatory Affairs, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant areas.
  
• Good understanding of regulatory affairs landscape
  
• Experience working with clinical trials
  
• Project management capabilities applicable to Regulatory Intelligence activities and oversight.
  
• Excellent interpersonal, verbal, and written communication skills, including the ability to present at meetings and training sessions.
  
• Ability to rapidly learn, understand, and apply applicable corporate procedures.
  
• Excellent time management skills, with the ability to prioritize workload and manage multiple tasks/projects with enthusiasm.
  
• Ability to lead projects and teams.
  
• Strong ability to analyze and interpret data.
  
• Attention to detail and advanced organizational skills.
  
• IT literate, with a strong ability to work with Microsoft-based applications and relevant Regulatory Intelligence applications such as Cortellis or Tarius
  
• Proficiency in written and oral English.