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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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