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

Parexel
Harrow
2 days ago
Applications closed

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About the Role

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.


Key Responsibilities
EU Product Information Management

  • 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

Operational Excellence

  • 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

Leadership & Collaboration

  • 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

Qualifications & Skills required for the role

  • 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


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