At a Glance
- Tasks: Lead regulatory affairs and develop labelling strategies for innovative pharmaceutical products.
- Company: Join a leading pharmaceutical company focused on impactful healthcare solutions.
- Benefits: Attractive salary, health benefits, flexible working options, and career development opportunities.
- Other info: Collaborative environment with opportunities for continuous improvement and growth.
- Why this job: Make a difference in global health by ensuring competitive product labelling.
- Qualifications: 8+ years in the pharmaceutical industry with strong labelling experience required.
The predicted salary is between 63000 - 77000 £ per year.
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 Sm PC, 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 BA accepted.
Advanced scientific degree (MSc, Ph D, or Pharm D) 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
Associate Director Regulatory Affairs in Hampshire employer: Freyr Solutions
As a leading employer in the Life Sciences sector, we offer a dynamic work environment that fosters innovation and collaboration. Our commitment to employee growth is evident through continuous training opportunities and a culture that values quality and integrity. Located in a vibrant area, our team enjoys a supportive atmosphere where every contribution is recognised, making it an ideal place for professionals seeking meaningful and rewarding careers.
