Senior Regulatory Affairs Consultant - Labelling (home or office based)

When our values align, there's no limit to what we can achieve.

We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist. This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams.

The role can be home or office based in various European locations.

• 
  
• Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
  
• Serve as the key point of contact for EU Product Information for both internal and external stakeholders
  
• Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
  
• Deliver competitive labelling searches and contribute to TCLP for early development assets
  

• 
  
• Ensure timely tracking and management of all EU Product Information in appropriate systems
  
• Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
  
• Coordinate Linguistic Review processes with LR Coordinator according to SOPs
  
• Communicate proactively with SPA for artwork and mock-up changes, participating in Change Control Processes
  

• 
  
• Lead the Local Labelling Committee for creation, review and approval of EU Product Information
  
• Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials
  
• Build strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teams
  
• Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements
  

• 
  
• University degree in a life science discipline
  
• Strong knowledge of EU regulatory requirements for product labelling and promotional materials
  
• Experience with electronic content management systems and regulatory SOPs
  
• Excellent project management and organizational abilities
  
• Outstanding written and verbal communication skills
  
• Proven ability to work effectively in cross-functional teams
  
• Fluent in English, written and spoken