Remote Global Labeling Operations Specialist

NEPSE Trading; Bogotá, Medellín; Hybrid; COP 40,000,000 - 70,000,000; Full time

Job summary

Fortrea Colombia is seeking a Labeling Operations Specialist to support creation and updates of labeling documents (CDS, USPI, SPC) for EU submissions and patient labeling. You will manage timelines, coordinate with labeling teams and regulators, and ensure documents meet QRD/PLR templates while maintaining logs and tracking systems.

Strong English communication, attention to detail, and proven project management skills are essential, with the ability to work effectively in a remote, global team.

Qualifications

• Bachelor's degree in science or life sciences required.
• Experience in regulated environment, pharmaceutical labeling preferred.
• Proven project management and attention to detail.

Responsibilities

• Generate labeling renditions (PDF/Word) and bookmarks.
• Manage labeling workflow and tracking systems.
• Coordinate with internal stakeholders and regulatory authorities.
• Prepare comparison tables and maintain CDS logs.

Skills

Regulatory labeling

Project management

English fluency

Attention to detail

Education

Bachelor's degree in science

Tools

MS Word

Labeling systems

Job description

Fortrea Colombia is seeking a Labeling Operations Specialist to support creation and updates of labeling documents (CDS, USPI, SPC) for EU submissions and patient labeling. You will manage timelines, coordinate with labeling teams and regulators, and ensure documents meet QRD/PLR templates while maintaining logs and tracking systems.

Strong English communication, attention to detail, and proven project management skills are essential, with the ability to work effectively in a remote, global team.