Remote Global Regulatory Labeling Specialist

Parexel; Boise (ID); Remote; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation/holiday/sick time

401(k) with company match

Pet Insurance

Job summary

Parexel is seeking a Global Labeling Specialist (Operations) to advance labeling governance and regulatory compliance across regions. This remote, international role emphasizes collaboration with Regulatory, Operations, and regional teams to manage labeling documents and ensure compliant updates throughout product lifecycles.

You will contribute to global regulatory labeling excellence, participate in lifecycle management, and support cross-functional teams in a fast-paced environment focused on

Qualifications

• 3+ years of pharmaceutical or biotechnology industry experience, including at least 2 years in regulatory labeling operations
• Direct experience with products developed through the full drug development and registration lifecycle in an innovator company
• Knowledge of global regulations, pharmacology, medicine, pharmacovigilance, and drug development

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 Change Management System is linked to Regulatory Tracking System
• Support development and maintenance of regulatory-compliant labeling documents throughout the product lifecycle (CDS, Global Patient Leaflet, Target Label Profile, EU Product Information, USPI)
• Distribute and track CDS updates, maintaining EDMs and regulatory tracking systems
• Track labeling updates across regions, supporting Regional and Local Regulatory Leads with Health Authority queries
• Maintain labeling compliance by version control and tracking in company systems, create/update labeling procedures and SOPs
• Provide training on labeling process requirements and stay current with global labeling regulations and governance standards

Skills

Regulatory labeling ops

Document management

Change management

Cross-functional collaboration

Regulatory affairs knowledge

Education

Bachelor's degree in science

Tools

Regulatory tracking systems

EDMS

SPL knowledge

Job description

Parexel is seeking a Global Labeling Specialist (Operations) to advance labeling governance and regulatory compliance across regions. This remote, international role emphasizes collaboration with Regulatory, Operations, and regional teams to manage labeling documents and ensure compliant updates throughout product lifecycles.

You will contribute to global regulatory labeling excellence, participate in lifecycle management, and support cross-functional teams in a fast-paced environment focused on