Senior Regulatory Affairs Consultant - Labelling; or office based

Position: Senior Regulatory Affairs Consultant - Labelling (home or office based)
Location: Via Milano

When our values align, there's no limit to what we can achieve.

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

EU Product Information Management :
Serve as the key point of contact for EU Product Information for both internal and external stakeholders

EU Product Information Management :
Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPsEU Product Information Management :
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

Operational Excellence :
Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports

Operational Excellence :
Coordinate Linguistic Review processes with LR Coordinator according to SOPsOperational Excellence :
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 Leadership & Collaboration :
Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials

Leadership & Collaboration :
Build strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teams

Leadership & Collaboration :
Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements

Qualifications & Skills 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 SOPsExcellent 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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