Remote Regulatory Labeling Operations Specialist

System One; Plainsboro Township (NJ); Remote; USD 100,000 - 120,000; Full time

Benefits offered by this job

Health benefits

PTO 20 days

Holidays 10

401k

Fully remote

Job summary

System One is seeking a Regulatory Affairs Labeling Operations Specialist to manage final printed pharmaceutical labeling for launch and lifecycle projects. You will ensure labeling content aligns with FDA Patient Labeling Resources and industry trends, coordinating with cross-functional teams to drive accurate, timely labeling.

The role requires deep knowledge of labeling tools (TVT, ALiCE/i4i, LIFT, SPL software) and a proven track record in quality control, proofreading, and regulatory

Qualifications

• 3–5+ years of labeling experience.
• Labeling development experience.
• SPL preparation & submission experience.
• Minimum 1 year, including validation error resolution.
• Strong technical knowledge of labeling systems (TVT, ALiCE / i4i, SPL tools, LIFT, Artwork Software).
• Manuel proofreading experience and familiarity with FDA Patient Labeling Resources and PLR format; global labeling experience.

Responsibilities

• Review and provide regulatory guidance on labeling materials to ensure CFR and FDA requirements.
• Identify labeling issues, troubleshoot, and coordinate timely resolutions with stakeholders.
• Monitor and improve labeling processes, quality, and tools in line with FDA regulations.

Skills

Labeling experience

Labeling development

SPL preparation

Validation error resolution

Labeling systems knowledge

Manual proofreading

FDA labeling resources

Global labeling experience

Tools

TVT

ALiCE / i4i

SPL tools

LIFT

Artwork Software

Vault RIM (Veeva)

Esko

Adobe Acrobat

Job description

System One is seeking a Regulatory Affairs Labeling Operations Specialist to manage final printed pharmaceutical labeling for launch and lifecycle projects. You will ensure labeling content aligns with FDA Patient Labeling Resources and industry trends, coordinating with cross-functional teams to drive accurate, timely labeling.

The role requires deep knowledge of labeling tools (TVT, ALiCE/i4i, LIFT, SPL software) and a proven track record in quality control, proofreading, and regulatory