Director of Regulatory Labeling - Remote

Overview

The Director, Regulatory Labeling manages the development, review, approval, and maintenance of the Company Core Data Sheets (CCDS), USPI, EU SmPC, and Rest of World (RoW) labeling, providing expertise and leading strategies across the product lifecycle.

In Short

• Manage the Regulatory labeling process throughout the product lifecycle.
• Lead the Labeling Working Group for CCDS, USPI, EU SmPC, and RoW labeling.
• Oversee complex labeling projects independently.
• Interpret labeling regulations and apply them to product situations.
• Develop target labeling documents for clinical trials.
• Communicate labeling rationales to management.
• Prepare submission-ready labeling documents.
• Monitor worldwide regulation changes in labeling.
• Mentor junior staff members in labeling expertise.
• Represent labeling team in external industry groups.

Requirements

• Bachelor’s degree in Life Sciences; advanced degree preferred.
• 10+ years of experience in Biotech or Pharma industry.
• 6+ years of experience specifically in labeling.
• Expert knowledge of FDA, EMA, and international labeling regulations.
• Ability to lead Labeling Working Groups.
• Strong analytical and strategic thinking skills.
• Attention to detail and strong word processing skills.
• Ability to handle multiple projects and work independently.
• Proactive information sharing and problem resolution skills.
• Ability to operate in ambiguous situations.

Benefits

• Comprehensive health and wellness programs.
• Fitness centers available for employees.
• Equity awards and annual bonuses.
• Paid time off for eligible employees.
• Inclusive and diverse workplace culture.