Regulatory Labeling Operations Specialist

The Fountain Group; Plainsboro Center (NJ); On-site; USD 76,000 - 92,000; Full time

Job summary

The Fountain Group is seeking a Regulatory Affairs Labeling Operations Specialist for a Plainsboro, NJ engagement. The role focuses on labeling development, verification, and lifecycle management, including SPL creation and electronic labeling verification.

This is an onsite‑preferred, remote‑considered 2-year contract with a strong emphasis on FDA/Health Canada compliance and cross‑functional collaboration.

Qualifications

• 3–5 years of pharmaceutical regulatory labeling experience.
• Hands-on SPL creation, development, and maintenance.
• Proficiency with TVT or equivalent labeling tools.
• Experience proofreading and reviewing labeling proofs.
• Knowledge of FDA labeling regulations (21 CFR, PLR, SRPI, IFU).
• Experience with regulatory labeling submissions and eCTD processes.
• Proficiency with Veeva Vault RIM, ALiCE, LIFT.
• Knowledge of FDA and Health Canada labeling requirements.
• Independent end-to-end labeling project management.

Responsibilities

• Review and proofread labeling artwork, including inserts, cartons and device labels.
• Develop, review, and maintain Structured Product Labeling (SPL) documents and submissions.
• Perform electronic labeling verifications using TVT and other tools.
• Ensure labeling compliance with FDA regulations and applicable requirements.
• Coordinate labeling projects with cross-functional teams.
• Develop project plans, timelines, and risk mitigation strategies.
• Support FDA submissions and product registrations.
• Support labeling process improvements using labeling platforms.

Skills

Pharma labeling experience

SPL creation

TVT proficiency

Proofreading artwork

FDA labeling regulations

eCTD submissions

Veeva Vault RIM

ALiCE

LIFT

FDA & Health Canada labeling

End-to-end project management

Education

Bachelor's degree in Regulatory Affairs/Life Sciences/Pharmacy

Minimum 3 years pharma/regulatory experience

Tools

TVT (Text Verification Tools)

Job description

The Fountain Group is seeking a Regulatory Affairs Labeling Operations Specialist for a Plainsboro, NJ engagement. The role focuses on labeling development, verification, and lifecycle management, including SPL creation and electronic labeling verification.

This is an onsite‑preferred, remote‑considered 2-year contract with a strong emphasis on FDA/Health Canada compliance and cross‑functional collaboration.