Global Labeling Operations Specialist, Regulatory Affairs

Parexel; Carson City (NV); Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Paid Time Off

401(k) match

Pet Insurance

Flexible Spending Account

Health Savings Account

Work-Life Balance

Job summary

Parexel is seeking a Global Labeling Specialist (Operations) to support labeling governance and regulatory compliance worldwide. This role focuses on document management, cross-functional collaboration, and ensuring timely labeling updates across regions.

You will work in a fast-paced, growth-oriented environment with opportunities to deepen expertise in global regulatory labeling and lifecycle management while contributing to patient safety outcomes.

Qualifications

• 3+ years in regulatory labeling operations within pharmaceutical/biotech
• Experience with full drug lifecycle labeling
• Knowledge of global labeling regulations and governance

Responsibilities

• Coordinate labeling operations and ensure regulatory-compliant labeling documents across regions
• Maintain version control and update labeling procedures/SOPs
• Support CDS, Global Patient Leaflet, and USPI labeling documents
• Track labeling updates across regions and respond to health authority queries

Education

Bachelor's degree in scientific discipline

Regulatory labeling operations

Document management systems

Change management

Cross-functional collaboration

Tools

EDMS

Regulatory tracking systems

SPL knowledge

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to support labeling governance and regulatory compliance worldwide. This role focuses on document management, cross-functional collaboration, and ensuring timely labeling updates across regions.

You will work in a fast-paced, growth-oriented environment with opportunities to deepen expertise in global regulatory labeling and lifecycle management while contributing to patient safety outcomes.