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Director, Global Regulatory Labelling
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Director, Global Regulatory Labelling
Full-time, permanent
Remote - can be based in the UK or Germany
Join a global biopharmaceutical organization dedicated to advancing innovative therapies for patients around the world. As the Director of Global Regulatory Labeling, you will lead the strategic development and execution of EU labeling while partnering with cross-functional global teams to ensure compliant, high-quality product labeling throughout the product lifecycle. Acting as a subject matter expert, you will influence global labeling strategy, support regulatory interactions, and drive the development of Company Core Data Sheets and regional labeling documents for innovative products. This is a highly visible leadership role offering the opportunity to shape global regulatory strategy, mentor colleagues, and contribute to continuous improvements across labeling processes and systems. The role can be remotely based across the UK or Germany.
Job Duties
- Lead the development and execution of EU labeling strategy, ensuring alignment with global regulatory strategy from early clinical development through commercialization and lifecycle management.
- Serve as the global subject matter expert for EU labeling and CCDS development, providing strategic guidance on labeling content, regulatory requirements, risk assessments, and implementation strategies.
- Collaborate with Regulatory Affairs, Clinical, Safety, Commercial, Medical Affairs, and external partners to support health authority interactions, negotiate labeling content, and optimize product labeling across global markets.
- Oversee the preparation, review, and maintenance of labeling documentation, including regulatory text, artwork, periodic safety reports, document management, and compliance with global labeling standards.
- Drive continuous improvement initiatives across global labeling processes, mentor junior team members, represent Global Labeling on cross-functional teams, and communicate strategic recommendations to senior leadership.
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Job Requirements
- Bachelor's degree in a scientific discipline required; MSc, PhD, or PharmD preferred, with 10+ years of pharmaceutical regulatory affairs or global labeling experience.
- Proven experience developing Company Core Data Sheets (CCDS), EU SmPCs, and other global labeling documents for new products, with a strong understanding of drug development and global regulatory requirements.
- Extensive knowledge of global labeling regulations, health authority interactions, regulatory submissions, and lifecycle labeling strategy, including experience assessing regulatory changes and competitor labeling.
- Strong leadership and project management experience, with the ability to influence cross-functional global teams, mentor colleagues, manage complex labeling initiatives, and drive strategic decision-making.
- Excellent communication, analytical, and problem-solving skills, with experience using Regulatory Information Management Systems (RIMS), electronic document management systems (EDMS), and a demonstrated ability to thrive in a collaborative, global matrix environment.
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Contact
To learn more, please apply to this job post. To connect directly with Amit, you can email him at amit.uma@meetlifesciences.com.
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