Associate Director, Global Regulatory Affairs Labeling Expert

1 day ago


Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job Overview

This role serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs).

Key Responsibilities

• Acts as point of contact for cross-functional teams on global labeling issues, ensuring compliance with all applicable regulations and guidelines.
• Independently manages, prepares, and implements regulatory documents, including USPI, annotated labeling, medication guides, EU SmPC, PIL, and CCDS.
• Leads cross-functional teams through all labeling discussions with the FDA/CHMP, ensuring management alignment and strategic planning for FDA meetings as needed.
• Ensures compliance with Core Data Sheets/label changes, managing updates to CCDS for assigned products and implementing CCDS/labeling agreements with licensing partners.
• Conducts Label Review Committee Meetings, preparing documents for review by labeling teams and ensuring appropriate governance for US, EU, and Company Core documents.
• Establishes processes and best practices, reinforcing labeling best practices at cross-functional meetings and assisting in the development of Standard Operating Procedures (SOPs) and process improvements.

Requirements

• Bachelor's Degree in a scientific discipline, with advanced degree (e.g., Masters, Pharm.D. or Ph.D.) preferred.
• 7 or more years of pharmaceutical industry experience, with 4 or more years of direct regulatory affairs experience, including US labeling experience, required.
• Experience with ex-US labeling (outside the US) preferred.

Travel

Ability to travel up to 10%.

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