Labeling Ops Specialist - Global Regulatory Docs, Remote

Fortrea; United States; Hybrid; USD 85,000 - 115,000; Full time

Job summary

Fortrea is seeking a Labeling Operations Specialist to manage the creation and updates of labeling documents (CDS, USPI, SPC) for products registered in the EU and US. You will oversee labeling review timelines, coordinate with internal stakeholders, and ensure documents meet SOPs and regulatory requirements.

The role requires strong attention to detail, English fluency, and demonstrated project management skills to drive timely delivery and high-quality labeling outputs for regional and global

Qualifications

• Bachelor’s degree in a science or life sciences required.
• 2-4 years experience in a regulated environment; pharmaceutical labeling experience preferred.

Responsibilities

• Generate necessary renditions (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
• Facilitate document workflow through corporate document repository
• Finalize documents post QC
• Utilize labeling tracking systems and perform system data quality checks
• Utilize text verification and proofreading tools
• Notify internal stakeholders of the availability of labeling documents
• Consolidate labeling versions
• Consolidate comments from Labeling reviewers and Regulatory Authorities
• Prepare comparison tables for labeling team discussions
• Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR)
• Update and maintain the CDS log
• Manage the document status in document management system
• Notify and communicate with internal stakeholders
• Set clear targets for review and approval timelines for labeling documents using effective project management
• Create SPL for USPIs and notify internal stakeholders of its availability
• Update related labeling documents for products within a similar class
• Provides shadowing opportunity to junior LOMs
• Ensure compliance to Company’s submission standards and SOPs.

Skills

Project management

Attention to detail

Communication skills

Problem solving

Education

Bachelor’s degree in science or life sciences

Tools

Microsoft Word

Job description

Fortrea is seeking a Labeling Operations Specialist to manage the creation and updates of labeling documents (CDS, USPI, SPC) for products registered in the EU and US. You will oversee labeling review timelines, coordinate with internal stakeholders, and ensure documents meet SOPs and regulatory requirements.

The role requires strong attention to detail, English fluency, and demonstrated project management skills to drive timely delivery and high-quality labeling outputs for regional and global