Responsibilities

• Act as labelling lead for assigned products, developing and maintaining global core labelling documents and major market labels (e.g. CDS, USPI, EU SmPC/PIL).
• Organise and facilitate cross-functional labelling discussions (e.g. ELTF meetings) to support alignment on content.
• Collaborate with Global Labelling colleagues and cross-functional teams to ensure consistent, compliant, and competitive labelling content.
• Conduct research across competitor labels, regulatory guidance, and clinical data to inform labelling updates.
• Prepare documentation to support labelling changes and contribute to responses to Health Authority queries.
• Support timely implementation of labelling updates across countries, ensuring alignment with global standards.
• Maintain high-quality documentation, including version control, references, and rationale for changes.
• Support audit and inspection readiness, mentoring colleagues where appropriate, and contributing to continuous improvement initiatives.

Requirements

• Fluency in English (written and spoken).
• Demonstrated capability in Global Labelling, Regulatory Affairs, or a related pharmaceutical discipline.
• Working knowledge of core labelling concepts and major market formats (e.g. CDS, USPI, EU SmPC/PIL).
• Ability to interpret clinical and safety data and translate it into clear, consistent labelling content.
• Strong attention to detail, with the ability to maintain accurate documentation and traceability.
• Ability to collaborate effectively across cross-functional teams and manage competing priorities.