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

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 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