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
* Strong partnership-building and influencing skills.
* Flexibility and adaptability in complex, ambiguous situations.
* Excellent communication and interpersonal skills.
* Results-oriented with strong problem-solving and analytical capabilities.
* Organizational skills and attention to detail.
* Commitment to integrity and compliance with regulatory standards.
Qualifications
* Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's or higher preferred).
* Experience in regulatory affairs, labelling, or promotional compliance within the pharmaceutical industry.
* Familiarity with EMA requirements and European regulatory frameworks.
* Fluent in English; additional European languages are an advantage.