Remote Regulatory Labeling Operations Specialist

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

Benefits offered by this job

Remote work

Health benefits

PTO & holidays

401k

Job summary

System One Clinical & Science is seeking a dynamic Regulatory Affairs Labeling Operations Specialist to manage final printed labeling for launch and lifecycle programs. You will verify leaflets, carton and container labels against FDA resources and collaborate with Regulatory Affairs, Global HQ, LPPC, Graphics, Marketing and Supply Chain to ensure labeling compliance and on-time inputs.

This fully remote USA-based position offers $100k–$120k annually, 20 days PTO, 10 holidays, 401k and optional

Qualifications

• 3–5+ years of labeling experience.
• Labeling development experience.
• SPL preparation and submission experience.
• Minimum 1 year, including validation error resolution.
• Strong knowledge of labeling systems (TVT, ALiCE/i4i, SPL tools, LIFT, Artwork Software).
• Manual proofreading experience (>70% of role).
• Familiarity with FDA Patient Labeling Resources and PLR format.
• True global labeling experience.

Responsibilities

• Review regulatory labeling materials for CFR and FDA requirements.
• Identify labeling issues, troubleshoot, and communicate effectively with stakeholders for timely resolution.
• Monitor, evaluate, and improve labeling processes and tools in line with FDA regulations and best practices.
• Participate in cross-functional teams locally and globally to troubleshoot problems of moderate scope and complexity.
• Assist in Final Printed Labeling review and approval to ensure on-time product labeling per launch timelines.
• Ensure filing requirements include SPL Drug Listing, FDA 2253s and Puerto Rico registrations.
• Label Development: coordinate with TA, LPPC, and Graphic Designers to meet launch readiness timelines.
• Labeling Tools: act as experienced user in SPL ALiCE A4L environment; TVT usage; coordinate IT support.

Skills

labeling experience

labeling development

SPL preparation

validation issue resolution

labeling systems (TVT/ALiCE/i4i)

proofreading

FDA labeling resources

global labeling

Tools

TVT

ALiCE / i4i

LIFT

Vault RIM (Veeva)

Esko

Adobe Acrobat

Job description

System One Clinical & Science is seeking a dynamic Regulatory Affairs Labeling Operations Specialist to manage final printed labeling for launch and lifecycle programs. You will verify leaflets, carton and container labels against FDA resources and collaborate with Regulatory Affairs, Global HQ, LPPC, Graphics, Marketing and Supply Chain to ensure labeling compliance and on-time inputs.

This fully remote USA-based position offers $100k–$120k annually, 20 days PTO, 10 holidays, 401k and optional