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

Parexel; Milano; Ibrido; EUR 45.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading regulatory affairs company is seeking an experienced Regulatory Affairs professional to join as a European Labelling & Promotional Regulatory Specialist. This role involves managing EU product information, ensuring compliance with labelling regulations, and collaborating with cross-functional teams. The ideal candidate will have a degree in life sciences, strong knowledge of EU regulatory requirements, and excellent organizational skills. This position can be home or office-based within various European locations.

Competenze

• Knowledge of electronic content management systems and regulatory SOPs.
• Strong understanding of key regulatory paths for product labelling.

Mansioni

• Manage EU Product Information in compliance with regulations.
• Lead reviews and approvals for EU Product Information.
• Coordinate Linguistic Review processes according to SOPs.

Conoscenze

Strong knowledge of EU regulatory requirements for product labelling and promotional materials

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

Formazione

University degree in a life science discipline

Descrizione del lavoro

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 SOPs
• EU 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 SOPs
• Operational 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 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