Global Labeling Lead

Freyr Solutions; Guildford; On-site; GBP 90,000 - 120,000; Full time

Job summary

Freyr Solutions seeks a Global Labeling Lead for a 10-12 month fixed-term role. Location includes Poland, UK, and other European countries.

You will lead labeling strategy, coordinate with cross-functional teams, and oversee labeling activities to ensure compliant, competitive product labeling. The role requires 8+ years in the pharmaceutical industry with substantial labeling experience, and advanced regulatory thinking to navigate US/EU labeling standards.

Qualifications

• 8+ years in pharmaceutical industry
• 6+ years labeling experience or 5+ years regulatory experience
• Strategic thinking to develop regulatory strategies based on requirements and priorities
• Strong communication to collaborate with global cross-functional teams
• Ability to transfer regulatory information clearly in written and oral formats

Responsibilities

• Escalate issues to Global Labeling management and propose risk mitigation.
• Develop labeling strategies and content with cross-functional teams (clinical, safety, medical affairs, commercial).
• Review labeling trends and precedent to align labeling with product strategy.
• Collaborate with Global Regulatory Team (GRT) and US/EU labeling operations to meet objectives.
• Support Health Authority inspections by providing labeling information for products.
• Oversee labeling activities managed by external vendors for assigned products.
• Contribute to continuous improvement of labeling processes for agility and accuracy.

Skills

Strategic Thinking

Communication

Regulatory Strategy

Cross-functional Collaboration

Regulatory Affairs

Education

BSc in Life Sciences

Advanced degree (MSc/PhD/PharmD) preferred

Job description

About Freyr

Freyr is a global Regulatory Solutions and Services organization supporting Life Sciences companies across Regulatory Affairs, Clinical, Safety, and Compliance. We partner with leading pharmaceutical, biotechnology, and medical device companies, delivering end-to-end regulatory operations support and regulatory strategy with precision, speed, and global expertise.

This is a 10 ~ 12 month fixed term role

Job Title: Global Labeling Lead

Location : Poland, UK , Romania, Hungary, Croatia, Czech Republic

Job Description

• Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products following global labeling communication guidance and proposes risk mitigation.
• 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 (TLP, CCDS, USPI, EU SmPC, others as appropriate) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure that Client products have the most competitive labeling possible; while maintaining awareness of recent in-class approvals.
• 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.

Education & Competencies (Technical and Behavioral)

• 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.
• Ability to use communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation formats.
• Ability to promote regulatory decisions across global cross-functional teams.