Global Labeling Strategy Lead

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

Job summary

Freyr Solutions seeks a Global Labeling Lead to shape regulatory labeling strategies across global teams, guiding labeling language and content for TLP, CCDS, USPI, EU SmPC, and related documents. You will collaborate with clinical, safety, medical affairs, and commercial groups to ensure alignment with the overall product strategy.

The role requires 8+ years in pharma with at least 6 years in labeling, strong strategic thinking, and superior communication across functions, plus a BA/BS with an

Qualifications

• BSc degree preferred; BA accepted.
• Advanced scientific degree preferred (MSc/PhD/PharmD).
• 8+ years of pharmaceutical industry experience, including 6 years labeling experience or combination of 5+ years regulatory and/or related experience.
• Strategic thinking to develop & execute regulatory strategies based on requirements, competition, and risk.
• Demonstrates an understanding of core business aspects and strong communication to collaborate with global teams.
• Ability to transfer regulatory information clearly in written, verbal, and presentation formats.

Responsibilities

• Escalates issues to Global Labeling management and GRL with proposed risk mitigation.
• Cultivates relationships across labeling cross-functional teams to ensure effective communication of labeling strategy.
• Conducts precedent searches and analyzes labeling trends to guide strategy (TLP, CCDS, USPI, EU SmPC).
• Represents Global Labeling at Global Regulatory Team and coordinates with US/EU labeling operations and Labeling Compliance.
• Participates in cross-functional task-forces and supports Health Authority inspections with labeling information requests.
• Oversees external labeling vendors to ensure timely delivery and adherence to quality standards.
• Contributes to continuous improvement of labeling processes for agility, accuracy, and efficiency.

Skills

Strategic Thinking

Communication

Cross-functional collaboration

Regulatory strategy

Regulatory labeling knowledge

Education

Bachelor's degree (BSc)

Advanced scientific degree (MSc, PhD, or PharmD) preferred

Job description

Freyr Solutions seeks a Global Labeling Lead to shape regulatory labeling strategies across global teams, guiding labeling language and content for TLP, CCDS, USPI, EU SmPC, and related documents. You will collaborate with clinical, safety, medical affairs, and commercial groups to ensure alignment with the overall product strategy.

The role requires 8+ years in pharma with at least 6 years in labeling, strong strategic thinking, and superior communication across functions, plus a BA/BS with an