Remote Global Labeling Operations Specialist

Parexel; Salt Lake City (UT); Remote; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending Account

Health Savings Account

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 for medicines on a global scale. This remote role focuses on governance, document management, and cross-regional collaboration to ensure compliant labeling throughout product lifecycles.

You will coordinate labeling activities, maintain CDS, EUPI, USPI documentation, and liaise with Regulatory and Artwork teams.

Qualifications

• 3+ years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations.
• Direct experience with products through the full drug development and registration lifecycle in an innovator company.
• Knowledge and understanding of 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 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, competitive, and high-quality labeling documents throughout the product lifecycle, including CDS, Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI), and USPI.
• Distribute and track CDS updates, maintaining compliance within the 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 and identifying country-specific labeling differences.
• Maintain labeling compliance by ensuring version control and tracking of labeling documents in relevant company systems, and create, maintain, and update regulatory labeling procedures and SOPs.
• Provide training to internal stakeholders and new joiners on labeling process requirements and maintain current knowledge of global labeling regulations and governance standards.

Skills

Regulatory labeling operations

Document management systems

Change management

Cross-functional collaboration

Global labeling requirements

Regulatory tracking systems

Strong communication

Education

Bachelor's degree in science/medical field

Tools

Electronic Document Management Systems (EDMS)

Regulatory tracking systems

Change management platforms

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to support labeling operations and regulatory compliance for medicines on a global scale. This remote role focuses on governance, document management, and cross-regional collaboration to ensure compliant labeling throughout product lifecycles.

You will coordinate labeling activities, maintain CDS, EUPI, USPI documentation, and liaise with Regulatory and Artwork teams.