Remote Global Labeling Operations Specialist

Parexel; Nashville (TN); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a Global Labeling Specialist (Operations) to join remotely, supporting labeling operations and regulatory compliance across regions. You will manage labeling documents, governance, and coordination with Regulatory, Operations, and regional teams throughout the product lifecycle.

The role emphasizes global labeling regulations, change management, and ensuring timely labeling updates, with opportunities to deepen expertise in regulatory affairs and clinical development.

Qualifications

• 3 years in pharmaceutical/biotech industry with 2+ years in regulatory labeling operations.
• Experience with product lifecycle labeling documentation (CDS, USPI, EU PI).
• Knowledge of global labeling regulations and regulatory governance.
• Strong communication, organization and problem-solving skills.

Responsibilities

• Coordinate labeling operations and changes with Regulatory/Labeling and Artwork teams.
• Track regulatory assessments and link Change Management System to Regulatory Tracking System.
• Develop and maintain regulatory labeling documents across product lifecycle (CDS, USPI, EU PI).
• Distribute CDS updates and ensure EDMS and tracking systems compliance.
• Monitor labeling updates across regions and respond to Health Authority queries.
• Maintain version control and update SOPs for labeling procedures.
• Provide training on labeling processes and maintain knowledge of global labeling standards.

Skills

Regulatory labeling operations

Document management systems

Change management processes

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree in life sciences

Tools

Document management systems

Regulatory tracking systems

Change management platforms

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to join remotely, supporting labeling operations and regulatory compliance across regions. You will manage labeling documents, governance, and coordination with Regulatory, Operations, and regional teams throughout the product lifecycle.

The role emphasizes global labeling regulations, change management, and ensuring timely labeling updates, with opportunities to deepen expertise in regulatory affairs and clinical development.