Global Labeling Operations Specialist - Remote

Parexel; Cheyenne (WY); Remote; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation Time

Sick Time

Flexible Spending Accounts

Health Savings Accounts

Work/Life Balance

401(k) Match

Pet Insurance

Job summary

Parexel is hiring a Global Labeling Specialist (Operations) to support labeling governance and regulatory compliance for innovative medicines. This remote role partners with Regulatory, Operations, and regional teams to manage CDS, EU PI, and USPI documents across product lifecycles.

You will ensure version control, maintain systems, and help train stakeholders on labeling requirements. Join a fast-paced team focused on regulatory excellence and cross-functional collaboration to deliver safe,

Qualifications

• 3+ years in pharmaceutical or biotechnology with regulatory labeling operations.
• 2+ years in regulatory labeling operations for innovative medicines.
• Knowledge of global labeling regulations and regulatory tracking systems.
• Strong communication and organizational skills.
• Understanding of labeling governance and compliance.
• Bachelor's degree or higher in a scientific discipline is preferred.

Responsibilities

• Coordinate labeling operations across Regulatory/Labeling and Artwork/Change Management teams.
• Link Change Management System to Regulatory Tracking System.
• Develop and maintain regulatory labeling documents across CDS, EU PI, USPI.
• Distribute CDS updates and track in EDMS and regulatory tracking systems.
• Track labeling updates across regions and respond to Health Authority queries.
• Maintain version control and update labeling procedures and SOPs.
• Provide training on labeling requirements to internal stakeholders.

Skills

Regulatory labeling operations

Document management systems

Change management processes

Global labeling regulations

Regulatory tracking systems

Cross-functional collaboration

Education

Bachelor's degree in a scientific or medically related discipline

Tools

EDMS

Regulatory tracking systems

Change management platforms

Job description

Parexel is hiring a Global Labeling Specialist (Operations) to support labeling governance and regulatory compliance for innovative medicines. This remote role partners with Regulatory, Operations, and regional teams to manage CDS, EU PI, and USPI documents across product lifecycles.

You will ensure version control, maintain systems, and help train stakeholders on labeling requirements. Join a fast-paced team focused on regulatory excellence and cross-functional collaboration to deliver safe,