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Senior Regulatory Affairs Consultant - Labelling

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Parexel

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Location:
United Kingdom , Remote

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

Job Responsibility:

  • 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 TLP 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 the Artworks team 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
  • Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements

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
What we offer:
  • Flexible work arrangements
  • Opportunities for career growth
  • Supportive and inclusive environment
  • Diverse and global client exposure
  • Learn from experts

Additional Information:

Job Posted:
January 20, 2026

Work Type:
Remote work
Job Link Share:

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