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

Experteer Italy; Italia; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading healthcare company is seeking an experienced Regulatory Affairs professional for the role of European Labelling & Promotional Regulatory Specialist. This position involves managing EU Product Information, collaborating with cross-functional teams, and ensuring compliance with EU regulatory standards. The ideal candidate will have a life science degree, solid project management skills, and fluency in English. This role can be based remotely in Italy.

Competenze

• Strong knowledge of EU regulatory requirements for product labelling and promotional materials.
• Experience with electronic content management systems and regulatory SOPs.
• Fluent in English, written and spoken.

Mansioni

• Create, update and maintain EU Product Information.
• Ensure timely tracking and management of EU Product Information.
• Lead the Local Labelling Committee.

Conoscenze

Knowledge of EU regulatory requirements

Project management

Communication skills

Formazione

University degree in a life science discipline

Strumenti

Electronic content management systems

Descrizione del lavoro

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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