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• Regulatory Labelling Lead jobs in the United Kingdom

4 Regulatory Labelling Lead jobs in the United Kingdom

Regulatory Labelling Lead

Posted 3 days ago

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Job Description

The Regulatory Labelling Lead role is part of a project with a leading biopharmaceutical company focused on developing innovative treatments for rare and ultra-rare genetic diseases. If you are passionate about working with a renowned organization committed to advancing research and supporting patients and families affected by these conditions, we encourage you to apply. This position offers the opportunity to collaborate with healthcare professionals, researchers, and advocacy groups, making a meaningful impact in the rare disease community. The role is fully remote and can be performed from anywhere in Europe. Join us and be part of our inspiring journey of growth!

Responsibilities:

• Overall accountability for creating and updating labeling documents
• Guide the labeling team in developing and maintaining Core Data sheets, USPI, SmPC, and related Patient Labeling documents, including regulatory authority-driven documents like Core Safety Profile
• Stay updated with labeling guidelines and regulations for development and maintenance of US and EU labeling
• Ensure compliance with key labeling requirements worldwide, reviewing downstream impacts of CDS updates on Local Product Documents (LPDs)
• Provide project management throughout the labeling process, from decisions to updates in CDS/USPI/SPC
• Review and sign off on labeling content to ensure regulatory compliance
• Facilitate understanding of regulatory issues across teams
• Contribute to system and process improvements at local and global levels

Requirements:

• 4-6 years of experience in Pharma or Medical Devices industry
• Hands-on registration experience in regulatory affairs related to development, maintenance, and commercialization
• Understanding of regulatory implications for product strategy and labeling
• Ability to interpret global and local regulatory guidance on labeling
• Excellent communication skills
• Strong analytical, writing, and logical skills
• Project management skills and attention to detail

Good to have skills:

• Understanding of CDS dynamics and review processes
• Experience with biologicals
• Opportunity to work in a fast-growing, multinational environment with major brands
• Potential for career growth and development
• Flexible, fully remote work environment across Europe
• Access to diverse benefits and training programs
• Competitive salary and reward schemes