Senior Global Labeling Operations Specialist (Remote)

Parexel; Frankfort (KY); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health, Vision & Dental 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 across regions and maintain regulatory labeling documents throughout the product lifecycle. This remote role collaborates with Regulatory, Operations, and regional teams to ensure compliant labeling and timely updates.

You will coordinate labeling activities, manage documents such as CDS, USPI, and EU Product Information, and contribute to regulatory excellence in a fast-paced environment.

Qualifications

• Experience in regulatory labeling operations within pharma/biotech
• Knowledge of global labeling requirements (SPL, FDA, EU)
• Proven ability to manage labeling documents across product lifecycle

Responsibilities

• Coordinate labeling activities and timelines with Regulatory/Labeling and Artwork/Change Management teams
• Maintain regulatory labeling documents and CDS/USPI/PI across systems
• Support regional implementation and respond to health authority inquiries

Skills

Regulatory labeling operations

Document management

Change management

Cross-functional collaboration

Regulatory communication

Attention to detail

Education

Bachelor’s degree in a scientific or medically related discipline

Tools

EDMS

Regulatory tracking systems

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to support labeling governance across regions and maintain regulatory labeling documents throughout the product lifecycle. This remote role collaborates with Regulatory, Operations, and regional teams to ensure compliant labeling and timely updates.

You will coordinate labeling activities, manage documents such as CDS, USPI, and EU Product Information, and contribute to regulatory excellence in a fast-paced environment.