Global Labeling Lead: Strategic Regulatory & Cross-Functional

Freyr Solutions; Park Central; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

Freyr Solutions seeks a Global Labeling Lead to guide labeling strategy across multiple regions including the UK, Poland, and Romania. The role involves cross-functional leadership, vendor oversight, and ensuring compliance with global labeling standards.

The position requires 8+ years in pharma labeling with strategic thinking and strong communication skills. This fixed-term assignment will drive labeling initiatives and support regulatory inspections, with a focus on timely, accurate labeling

Qualifications

• BSc degree, preferred; BA accepted.
• Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of labeling experience or combination of 5+ years regulatory and/or related experience.
• Strategic Thinking - Ability to develop & execute clear and practical regulatory strategies based on regulatory requirements, competitive landscape, key priorities and risk management.
• Demonstrates an understanding of core business aspect.
• Communication - Ability to effectively collaborate with global cross-functional teams.

Responsibilities

• Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling guidance.
• Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams including clinical, safety, medical affairs, and commercial, to ensure the highest level of communication effectiveness for labeling strategy and content.
• Precedent Search and Labeling Trends - Conducts precedent, analyzes relevant competitor labeling, health authority labeling requests for Client products, labeling guidance and trends; and develops strategies and labeling language for assigned product labels to ensure consistency with the product strategy.
• Working within Labeling Team and GRA - Represents Global Labeling at Global Regulatory Team (GRT) - Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met.
• Represents global labeling in departmental and cross-functional task-forces and initiatives.
• Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
• Vendor Management - Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
• Continuous Improvement - Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.

Skills

Strategic Thinking

Communication

Cross-functional collaboration

Education

BSc degree

Advanced scientific degree

Job description

Freyr Solutions seeks a Global Labeling Lead to guide labeling strategy across multiple regions including the UK, Poland, and Romania. The role involves cross-functional leadership, vendor oversight, and ensuring compliance with global labeling standards.

The position requires 8+ years in pharma labeling with strategic thinking and strong communication skills. This fixed-term assignment will drive labeling initiatives and support regulatory inspections, with a focus on timely, accurate labeling