Global Labeling Lead: Strategic Cross-Functional Leader

Freyr Solutions; Bolton; On-site; GBP 90,000 - 140,000; Full time

Job summary

Freyr Solutions in the United Kingdom seeks a Global Labeling Lead to drive regulatory labeling strategy across US, EU, and global markets. You will lead cross-functional teams, manage labeling content (USPI, SmPC), and collaborate with the Global Regulatory Lead and vendors to ensure compliant, competitive labeling.

The role requires extensive regulatory experience, strong communication skills, and a strategic mindset to navigate global labeling requirements and inspections.

Qualifications

• BSc degree preferred; BA accepted.
• Advanced scientific degree (MSc, PhD, or PharmD) preferred.
• 8+ years of pharmaceutical industry experience, including 6 years labeling or 5+ years regulatory experience.
• Strategic thinking to develop regulatory strategies based on requirements and risk.
• Strong communication and ability to collaborate across global teams.
• Ability to transfer knowledge and promote regulatory decisions across global functions.

Responsibilities

• Escalates issues to Global Labeling management and the Global Regulatory Lead, proposing risk mitigation strategies.
• Develops relationships among cross-functional labeling teams (clinical, safety, medical affairs, commercial) for effective labeling strategy and content.
• Performs precedent searches and analyzes labeling trends to craft labeling language (TLP, CCDS, USPI, EU SmPC) aligned with product strategy.
• Represents Global Labeling in Global Regulatory Team and coordinates with US/EU Labeling Operations and other leads to meet objectives.
• Supports Health Authority inspections by providing labeling information requests related to products and processes.
• Oversees external labeling vendors to ensure timely delivery and adherence to quality standards.
• Contributes to continuous improvement of labeling processes to enhance agility, efficiency and accuracy.

Skills

Strategic Thinking

Cross-functional Collaboration

Regulatory Knowledge

Communication

Stakeholder Management

Education

BSc/BA degree

Advanced scientific degree (MSc/PhD/PharmD)

Job description

Freyr Solutions in the United Kingdom seeks a Global Labeling Lead to drive regulatory labeling strategy across US, EU, and global markets. You will lead cross-functional teams, manage labeling content (USPI, SmPC), and collaborate with the Global Regulatory Lead and vendors to ensure compliant, competitive labeling.

The role requires extensive regulatory experience, strong communication skills, and a strategic mindset to navigate global labeling requirements and inspections.