Remote Regulatory Labeling Specialist

Parexel; United States; Remote; USD 120,000 - 140,000; Full time

Job summary

Parexel is seeking a Regulatory Labeling Specialist to join remotely. You will ensure medicinal product labeling remains accurate, compliant, and current across lifecycle, collaborating with cross-functional teams and clients to support regulatory outcomes.

You will work with Health Authority submissions, CCDS updates, and post-approval activities in Veeva RIMS and TrackWise, contributing to a fast-paced, growth-focused environment that prioritizes patient safety and regulatory excellence.

Qualifications

• Bachelor's degree in Life Sciences or related field with 6+ years in regulatory labeling.
• Experience with Health Authority submissions and CCDS updates.
• Proficiency in English with strong written and verbal communication.
• Knowledge of Veeva RIMS and TrackWise workflows.

Responsibilities

• Perform regulatory impact assessments for change controls and submissions.
• Manage product information updates, including CCDS creation and updates.
• Prepare and submit variations, notifications, and renewals to Health Authorities.
• Respond to Health Authority questions on submissions.
• Coordinate labeling updates and translations with team members and clients.

Skills

Regulatory labeling

Veeva RIMS

TrackWise

Cross-functional collaboration

English fluency

Project coordination

Education

Bachelor’s degree in Life Sciences

Tools

Veeva RIMS

TrackWise

Job description

Parexel is seeking a Regulatory Labeling Specialist to join remotely. You will ensure medicinal product labeling remains accurate, compliant, and current across lifecycle, collaborating with cross-functional teams and clients to support regulatory outcomes.

You will work with Health Authority submissions, CCDS updates, and post-approval activities in Veeva RIMS and TrackWise, contributing to a fast-paced, growth-focused environment that prioritizes patient safety and regulatory excellence.