Regulatory Global Labeling Director - Remote

Overview

The Director of Regulatory Global Labeling (REG-GL) is a strategic leadership role working with a team to develop and manage labeling for products worldwide. Responsibilities may include developing labeling content and strategies for Target Product Labeling, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for Use.

In Short

• Lead or direct the creation of high-quality labeling and supporting documents.
• Manage compliance of local labeling against approved CCDS concepts.
• Lead Product Labeling Teams to ensure compliance with local regulations.
• Present and defend proposed labeling changes to management.
• Provide regulatory strategic guidance for global labeling activities.
• Responsible for the development of labeling negotiations strategic plans.
• Create and lead the development of labeling processes.
• Guide launch teams on launch strategy for new commercial products.
• Collaborate with cross-functional teams for labeling claims.
• Ensure proper handoff and compliance in the labeling process.

Requirements

• Minimum of 7 years of industry experience, with at least 4 years in labeling.
• Experienced leader with management and direct reports.
• Experience negotiating complex regulatory issues.
• Thorough understanding of regulatory labeling requirements.
• Outstanding interpersonal and communication skills.
• Excellent writing skills with attention to detail.
• Prior experience leading cross-functional teams.
• Fluency in English; additional languages advantageous.
• Expertise in global labeling and managing project teams.
• US labeling expertise required.

Benefits

• Opportunity to work in a strategic leadership role.
• Engagement in global product labeling processes.
• Collaboration with cross-functional teams.
• Professional development opportunities.
• Ability to influence regulatory strategies.