Global Labeling Strategy Lead

ThermoFisher Scientific; Brussel Hoofdstad; Sur place; EUR 120 000 - 180 000; Plein temps

Résumé du poste

Thermo Fisher Scientific in Belgium is seeking a Regulatory Affairs Associate Director- Labeling strategist to lead global labeling strategy and author key documents such as TPL, Core Data Sheet, and PI for both new and existing assets. You will work cross-functionally with regional leads to align labeling content with development data, regulatory intelligence, and market needs.

You will guide projects from preclinical stages through registration, provide regulatory expertise to clients, chair

Qualifications

• Bachelor’s degree in life sciences or related field.
• At least 5 years of experience in global labeling strategy.
• Experience with biologics, medical devices, or combined products.

Responsabilités

• Define and monitor labeling plans with GRL and PMs.
• Lead labeling strategy with cross-functional teams across regions.
• Author Target Product Label (TPL) and core documents.
• Chair labeling groups and participate in global/regional committees.
• Contribute to global regulatory team meetings and submissions.
• Provide regulatory intelligence and project governance support.
• Review source documents and contribute to eCTD modules.
• Supervise US label activities and ensure labeling plan execution.

Connaissances

Global labeling

Regulatory leadership

Cross-functional teamwork

Project management

Stakeholder management

Formation

Bachelor's degree in life sciences

Outils

Veeva Vault

MS Office

Description du poste

Thermo Fisher Scientific in Belgium is seeking a Regulatory Affairs Associate Director- Labeling strategist to lead global labeling strategy and author key documents such as TPL, Core Data Sheet, and PI for both new and existing assets. You will work cross-functionally with regional leads to align labeling content with development data, regulatory intelligence, and market needs.

You will guide projects from preclinical stages through registration, provide regulatory expertise to clients, chair