Remote-Ready Regulatory Labeling Ops Specialist (Contractor)

GForce Life Sciences; Plainsboro Township (NJ); On-site; USD 83,000 - 124,000; Full time

Job summary

GForce Life Sciences is engaged to support a Regulatory Affairs Labeling Operations Specialist (Contractor) in Plainsboro, NJ, onsite preferred with some remote options. The role encompasses final printed labeling for launch and lifecycle management, verification across leaflets, cartons, and device labels, and providing regulatory guidance to ensure CFR/FDA compliance.

Ideal candidates will have a Bachelor's degree and at least 3 years in a pharmaceutical labeling environment, with hands-on

Qualifications

• Bachelor’s degree plus minimum 3 years of experience in pharmaceutical labeling or regulatory environment.
• Experience with SPL, ALiCE/A4L and TVT tools.
• Proficiency with 21 CFR labeling, PLR, SRPI, FDA labeling resources and NDCs.
• Ability to independently manage labeling processes and drive outcomes.
• Collaborate effectively with cross-functional teams.

Responsibilities

• Process final printed pharmaceutical labeling tasks for launch and lifecycle projects.
• Perform labeling verification across leaflets, cartons, container labels, and device labels.
• Review commercial labeling materials and provide regulatory guidance for compliance.
• Identify labeling issues and coordinate with stakeholders for timely resolution.
• Monitor improvements to labeling processes, systems, and tools per FDA regulations.

Skills

Regulatory labeling

Cross-functional collaboration

Attention to detail

Project management

Education

Bachelor’s degree in life sciences or related field

3+ years labeling/regulatory experience

Tools

SPL (Structured Product Labeling)

ALiCE/A4L

TVT (Text Verification Tool)

Job description

GForce Life Sciences is engaged to support a Regulatory Affairs Labeling Operations Specialist (Contractor) in Plainsboro, NJ, onsite preferred with some remote options. The role encompasses final printed labeling for launch and lifecycle management, verification across leaflets, cartons, and device labels, and providing regulatory guidance to ensure CFR/FDA compliance.

Ideal candidates will have a Bachelor's degree and at least 3 years in a pharmaceutical labeling environment, with hands-on