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 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