Senior Regulatory Affairs Consultant

2 days ago

United KingdomHarrowRemote, United Kingdom Parexel Full time £60,000 - £90,000 per year

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 TLP 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 the Artworks team 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

  • 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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