At a Glance
- Tasks: Lead global labeling strategies and collaborate with cross-functional teams to enhance product communication.
- Company: Freyr, a leader in regulatory solutions for life sciences.
- Benefits: Competitive salary, flexible work locations, and opportunities for professional growth.
- Other info: Join a dynamic team focused on continuous improvement and global collaboration.
- Why this job: Make a real impact in the pharmaceutical industry while working with innovative teams.
- Qualifications: 8+ years in pharma, with strong labeling and strategic thinking skills.
The predicted salary is between 70000 - 90000 £ per year.
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.
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.
- 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.
- Conducts precedent searches, analyses relevant competitor labeling, health authority labeling requests for Client products, labeling guidance and trends; 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.
- 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.
- Supports Health Authority Inspections (US, EU, and Global) by providing labeling information requests related to assigned products and overall labeling processes.
- Oversight and accountability for labeling activities managed by external vendor(s) for assigned products, ensuring seamless coordination, timely delivery, and adherence to quality standards.
- Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiency and accuracy.
Education: 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.
Global Labeling Lead employer: Freyr Solutions
Freyr is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals in the Life Sciences sector. With a strong emphasis on employee growth and development, Freyr offers numerous opportunities for advancement while supporting a diverse range of projects across multiple countries, including Poland, the UK, Romania, Hungary, Croatia, and the Czech Republic. Employees benefit from a dynamic environment that encourages strategic thinking and continuous improvement, ensuring that every team member can contribute meaningfully to the success of global regulatory operations.
