Global Labeling Strategy Lead

Freyr Solutions

Cardiff

On-site

GBP 90,000 - 140,000

Full time

9 days ago

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Job summary

Freyr Solutions in the United Kingdom is seeking a Global Labeling Lead to drive regulatory labeling strategy and cross-functional collaboration across global markets. You will coordinate with clinical, safety, medical affairs and commercial teams to ensure labeling compliance with CCDS, USPI and EU SmPC standards.

The role requires strong strategic thinking and exceptional communication to translate regulatory requirements into actionable content and timelines.

Qualifications

8+ years of pharmaceutical industry experience with labeling experience or related regulatory exposure.
Ability to develop and execute regulatory strategies based on requirements, landscape and risks.
Strong business sense and ability to translate regulatory needs to cross-functional teams.
Excellent written and verbal communication to transfer knowledge and present complex regulatory information.

Responsibilities

Escalate issues to Global Labeling management and GRL with proposed risk mitigation strategies.
Develop labeling strategy and language for TLP, CCDS, USPI, EU SmPC ensuring consistency with product strategy.
Represent Global Labeling in GRT and liaise with US/EU Labeling Operations to meet objectives and timelines.
Support Health Authority inspections by providing labeling information requests and documenting processes.
Oversee external labeling vendors to ensure timely delivery and adherence to quality standards.
Contribute to continuous improvement of labeling processes to enhance agility, efficiency and accuracy.