Director Global Labelling

Location: Europe | Global Regulatory Affairs

Overview

An exciting opportunity has arisen for a Director Global Labeling to lead strategic labeling activities within a global pharmaceutical environment. This role will be responsible for developing and maintaining EU and global product labeling, ensuring regulatory compliance and supporting product development and lifecycle management.

Working closely with cross-functional teams, regulatory stakeholders and global affiliates, the successful candidate will provide strategic labeling expertise, guide complex regulatory decisions and drive high-quality labeling documentation. This is a senior leadership position requiring strong technical knowledge, strategic thinking and the ability to influence stakeholders across a global, matrixed organisation.

Key Responsibilities

• Lead EU labeling strategy in alignment with global regulatory strategies, covering product development through to lifecycle management.
• Provide expert guidance on the development and maintenance of EU SmPCs, Company Core Data Sheets (CCDS) and other global and regional labeling documents.
• Assess labeling changes, regulatory updates and associated risks, advising on implementation strategies and potential impacts across regions.
• Support Health Authority interactions, including labeling negotiations, review comments and the development of alternative proposals.
• Evaluate competitor labeling and regulatory precedents to identify opportunities for label optimization and product differentiation.
• Collaborate with Regulatory Affairs, Medical Affairs, Commercial and other cross-functional stakeholders to ensure labeling strategies meet regulatory and business needs.
• Partner with Labeling Operations to ensure accurate and compliant labeling artwork, translations, linguistic reviews and supporting documentation.
• Maintain labeling documentation and contribute to periodic safety reports, regulatory inquiries, audits and inspection readiness.
• Monitor labeling compliance metrics, investigate deviations and drive continuous improvement across labeling processes, policies and systems.
• Lead product-specific regulatory and cross-functional teams, providing strategic direction, mentoring and guidance to colleagues.
• Communicate labeling strategies, risks and decisions clearly to senior management and key stakeholders.
• Promote early labeling development, global strategic thinking and consistency between global and local product labeling.

Requirements

• Bachelor's degree in a scientific discipline; an advanced degree such as an MSc, PhD or PharmD is preferred.
• At least 10 years of relevant experience in pharmaceutical labeling and/or regulatory affairs.
• Demonstrable experience developing and authoring Company Core Data Sheets (CCDS) and EU labeling documents for new products.
• Strong understanding of global pharmaceutical regulatory requirements, labeling guidelines and regulatory systems.
• Excellent knowledge of medical concepts, scientific principles and pharmaceutical terminology.
• Experience managing complex regulatory projects and influencing decisions across global, cross-functional teams.
• Strong written and verbal communication skills in English, including the ability to present complex regulatory information clearly.
• Experience with regulatory information management systems (RIMS) and electronic document management systems (EDMS) is advantageous.
• Proven leadership skills, with the ability to mentor colleagues, manage competing priorities and drive continuous improvement.
• Excellent problem-solving, decision-making and stakeholder management capabilities.
• A proactive, commercially aware and solutions-focused approach, with the ability to navigate ambiguity and deliver results in a dynamic global environment.

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