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Regulatory Affairs Associate II

Mindlance · Posted Nov 4, 2026

Plainsboro, New Jersey, United States
Contract · Associate
BILL RATE: up to ***
3–5 years

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Regulatory Affairs Labeling Operations Specialist (Contractor) responsible for final printed pharmaceutical labeling compliance and lifecycle management.

Responsibilities

Review and provide regulatory guidance on commercial labeling materials to ensure compliance with CFR and FDA labeling requirements
Identify labeling issues, troubleshoot, and communicate effectively with relevant stakeholders to ensure timely resolution
Monitor, evaluate, and recommend improvements to labeling processes, quality, and system tools, in alignment with FDA regulations and industry best practices
Assist in the Final Printed Labeling review and approval process based on final approved labeling content from FDA, collaborating with TA, LPPC, and Graphic Designers to ensure successful on-time launch of product labeling per company launch readiness timelines
Ensure additional filing requirements are completed for approved content of labeling to include SPL Drug Listing, FDA 2253s and Puerto Rico Registrations

Requirements

Bachelor's degree
Nice to have: brand experience

Skills

TVT SPL Self-Directed Project Management

Project Manager

Project Manager

Responsibilities

Requirements

Skills

Regulatory Affairs Associate II

Responsibilities

Requirements

Skills