Remote Global Labeling Operations Specialist

Parexel; Denver (CO); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Global Labeling Specialist (Operations) to support labeling operations and regulatory compliance across regions from a remote capacity. You will manage labeling documents, ensure governance, and collaborate with Regulatory, Operations, and regional teams globally.

This role focuses on CDS, USPI, SPL-related documentation, and ongoing labeling changes through the product lifecycle, with opportunities to deepen expertise in global regulatory labeling and governance.

Qualifications

• 3 years of pharmaceutical or biotechnology experience, including regulatory labeling operations.
• Experience with products through full drug development and registration lifecycle.
• Knowledge of global labeling regulations and governance standards.

Responsibilities

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management to ensure artwork activity changes are communicated.
• Record regulatory assessments and link Change Management System to Regulatory Tracking System.
• Develop and maintain regulatory-compliant labeling documents (CDS, USPI, EU IP, etc.).
• Distribute CDS updates and maintain EDMS/regulatory tracking compliance.
• Track labeling updates across regions and support country-specific labeling differences.
• Maintain labeling procedures and SOPs; provide training on labeling requirements.

Skills

Regulatory labeling operations

Document management systems

Change management

Cross-functional collaboration

Regulatory tracking systems

Education

Bachelor’s degree in a scientific discipline

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to support labeling operations and regulatory compliance across regions from a remote capacity. You will manage labeling documents, ensure governance, and collaborate with Regulatory, Operations, and regional teams globally.

This role focuses on CDS, USPI, SPL-related documentation, and ongoing labeling changes through the product lifecycle, with opportunities to deepen expertise in global regulatory labeling and governance.