Regulatory Affairs Associate II
Mindlance · Posted Nov 4, 2026
- Plainsboro, New Jersey, United States
- Contract · Associate
- BILL RATE: up to ***
- 3–5 years
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