Global Labeling Operations Specialist — Remote

Parexel; Augusta (ME); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation Time

Health Savings Account

Work-Life Balance

401k Match

Pet Insurance

Job summary

Parexel is seeking a Global Labeling Specialist (Operations) to join our team remotely. You will support labeling operations, regulatory compliance, and governance across regions, managing documents like CDS, USPI, and EU Product Information.

This role collaborates with Regulatory, Operations, and regional teams to ensure timely labeling updates, maintain version control, and uphold labeling standards throughout product lifecycles.

Qualifications

• 3+ years in pharmaceutical or biotechnology labeling operations.
• Experience with products through full drug development lifecycle.
• Knowledge of global labeling regulations and pharmacovigilance.
• Proven experience with document management systems and tracking.

Responsibilities

• Act as liaison between Regulatory/Labeling and Artwork/Change Management teams.
• Record regulatory assessments and link Change Management to Regulatory Tracking.
• Develop and maintain regulatory labeling documents across CDS, USPI, and EU PI.
• Distribute CDS updates and ensure EDMS compliance and tracking.
• Track labeling updates across regions and respond to health authority queries.
• Maintain version control and update labeling procedures and SOPs.
• Provide training on labeling processes and regulatory governance.

Skills

Regulatory labeling operations

Document management systems

Change management

Education

Bachelor's degree in scientific discipline

Tools

EDMS

Regulatory tracking systems

Change management platforms

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to join our team remotely. You will support labeling operations, regulatory compliance, and governance across regions, managing documents like CDS, USPI, and EU Product Information.

This role collaborates with Regulatory, Operations, and regional teams to ensure timely labeling updates, maintain version control, and uphold labeling standards throughout product lifecycles.