Senior Regulatory Affairs Manager (Labeling)- FSP

Global Labeling & Lifecycle Document Specialist

At Thermo Fisher Scientific Inc., you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital, and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Summarized Purpose

The Global Labeling & Lifecycle Document Specialist (GL&LDS) Team is responsible for managing global labeling activities and ensuring compliance with international regulatory standards. This role coordinates all aspects of labeling processes across foundational and dependent markets, including the preparation, submission, and maintenance of labeling documents. The position requires strong organizational, technical, and regulatory expertise to manage complex global labeling operations within a matrixed environment.

Responsibilities

• Coordinate readability testing, translations, and linguistic reviews for foundational markets (EU, CH, DE).
• Manage the preparation, review, and upload of approved labels to internal systems (Documentum, Weblabel, intranet) and external platforms (HA, ePIL).
• Dispatch CCDS, foundational labels, and multi-market manuscripts to dependent markets, collaborators, and partners.
• Coordinate and perform data entry for labeling systems (Trackwise, Veeva) and maintain labeling records.
• Maintain and update Company Core Data Sheet (CCDS), US Prescribing Information (USPI), and EU Summary of Product Characteristics (SmPC).
• Lead Global Labeling Committee (GLC) evaluations and handle exceptions between CCDS and regional labels.

Governance & Compliance

Regulatory & Cross-Functional Support

Clinical Trial Regulatory Responsibilities

Operational & Administrative Activities

Qualifications

Education and Experience

Technical Skills

Proficiencies