Regulatory Affairs

Role OverviewThe 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 ResponsibilitiesCreate, 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 & SkillsStrong 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.QualificationsBachelor'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.