Regulatory Affairs - Labelling

Role Overview

The European Labelling & Promotional Scientist provides regulatory expertise for labelling and promotional activities across a therapeutic business unit. This role delivers strategic and operational input to cross-functional teams, ensuring compliance with European regulatory requirements and supporting safe and effective product use.

Key Responsibilities

• Create, update, and maintain EU Product Information (SmPC, Label, PIL, IFU) in line with core data sheets, agency requirements, and current labelling standards.
• Act as the primary point of contact for EU labelling matters, leading reviews, approvals, and ensuring timely updates in relevant systems.
• Manage readability testing, including vendor selection, agreement oversight, and submission of final reports.
• Oversee linguistic review processes and ensure accurate communication of approved labels to internal and external stakeholders.
• Collaborate with artwork and packaging teams on mock-up changes and participate in change control processes.
• Lead local labelling committees and contribute to discussions on packaging requirements (e.g., QR codes, language compliance).
• Serve as the regulatory reviewer for promotional materials, ensuring compliance with codes of conduct, regulations, and approved product information.
• Build strong relationships with regulatory teams, commercial, medical affairs, and other business partners to align on labelling and promotional strategies.
• Monitor changes in EMA labelling requirements and communicate updates across the organization.

Required Competencies & Skills

Qualifications