Job Title: Senior Regulatory Affairs Consultant - Labelling (home or office based)
Job Location: Uxbridge, UK
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
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
* 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 the 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 and 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 organisational 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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