Global Labelling Strategist - Remote

Overview

We are seeking an experienced Global Labelling Strategist to join our Global Regulatory Strategic Operations team, part of Global Regulatory and Safety Sciences. The ideal candidate will be responsible for driving global labelling strategies and managing the development, review, and maintenance of key labelling documents such as the Target Label Profile (TLP), Company Core Data Sheet (CCDS), United States Package Insert (USPI), and EU Summary of Product Characteristics (SmPC).

In Short

• Develop and execute global labelling strategies in partnership with the Global Regulatory Team Leader.
• Provide labelling expertise across CCDS, USPI, and SmPC for both Development and Lifecycle Management projects.
• Act as the primary liaison for the Cross-Functional Labelling Team.
• Coordinate labelling activities among multifunctional teams.
• Oversee planning and execution of all cross-functional labelling activities.
• Support responses to global health authority inquiries related to labelling.
• Review country-specific labels for compliance with global standards.
• Mentor and provide training for other Global Labelling Leads.
• Lead or contribute to process improvement initiatives.
• Identify opportunities to influence regulatory policies.

Requirements

• Master’s degree in Life Sciences or equivalent with at least 5 years of labelling experience, or Bachelor’s degree with at least 7 years of labelling or regulatory experience.
• Strong understanding of global labelling guidelines.
• In-depth knowledge of Company Core Data Sheets and their regulatory implications.
• Proven ability to interpret regulatory requirements.
• Excellent communication and collaboration skills.
• Strong analytical and problem-solving abilities.

Benefits

• Confidentiality of personal information will be maintained according to EEO guidelines.