Global Labeling Operations Specialist

Parexel; Columbia (SC); 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 governance, regulatory compliance, and document management across regions in a remote capacity. You will coordinate labeling activities, manage regulatory-compliant documents, and collaborate with Regulatory, Operations, and regional teams to ensure accurate labeling throughout product lifecycles.

The role emphasizes knowledge of global labeling regulations, change management processes, and cross-functional

Qualifications

• 3 years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations
• Direct experience with products developed through the full drug development and registration lifecycle in an innovator company environment
• Knowledge and understanding of applicable global regulations, pharmacology, medicine, pharmacovigilance, and drug development
• Proven experience with document management systems, regulatory tracking systems, and change management platforms
• Strong communication, organization, and problem-solving skills
• Demonstrated understanding of the importance of labeling governance and compliance

Responsibilities

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management teams to ensure changes to planned artwork activities and implementation timelines are communicated effectively
• Record regulatory assessments and ensure the Change Management System is appropriately linked to the Regulatory Tracking System
• Support the development and maintenance of regulatory-compliant, high-quality labeling documents throughout the product lifecycle
• Distribute and track CDS updates, maintaining compliance within EDMS and regulatory tracking systems
• Track implementation of labeling updates across regions and countries, supporting Regional and Local Regulatory Leads in responding to Health Authority queries
• Maintain labeling compliance by ensuring version control and tracking of labeling documents in relevant company systems
• Provide training to internal stakeholders on labeling process requirements and maintain knowledge of global labeling regulations and governance standards

Skills

Regulatory labeling operations

Global labeling regulations

Cross-functional collaboration

Attention to detail

Regulatory documentation

Communication skills

Education

Bachelor’s degree in a scientific or medically related discipline

Tools

Document management systems

Regulatory tracking systems

Change management platforms

EDMS

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to support labeling governance, regulatory compliance, and document management across regions in a remote capacity. You will coordinate labeling activities, manage regulatory-compliant documents, and collaborate with Regulatory, Operations, and regional teams to ensure accurate labeling throughout product lifecycles.

The role emphasizes knowledge of global labeling regulations, change management processes, and cross-functional