Global Regulatory Labeling Strategy Lead

Travere Therapeutics; Wichita (KS); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego is seeking an Associate Director, Labeling Strategy to lead global labeling across the product lifecycle. You will guide development of labeling content, coordinate with Regulatory Affairs, Clinical Development, and Legal, and drive alignment with Health Authority expectations.

The role requires extensive experience in USPI and EU SmPC labeling, strong project management, and ability to influence senior leadership.

Qualifications

• Bachelor's degree in a scientific discipline required.
• 8+ years of relevant pharmaceutical or biotech experience with 6+ years in labeling.
• Strong knowledge of US and EU labeling requirements (USPI and EU SmPC).

Responsibilities

• Leads Labeling multi-disciplinary team to align labeling strategy and content.
• Coordinates the process to obtain labeling approval by ELB.
• Authors TPL, CCDS, and USPI for assigned products with input from all functions.
• Develops and executes global labeling implementation plans with new data and Health Authority responses.
• Manages communications regarding CCDS and labeling updates.
• Demonstrates project management to coordinate global labeling functions and negotiations.
• Interprets regulations and guidance to ensure labeling content meets requirements.
• Mentors Local Labeling Leads for responses to health authorities.
• Presents issues to Executive Labeling Board for risk mitigation and negotiation strategies.
• Analyzes competitor labeling and trends to guide labeling language (TPL/CCDS/USPI).
• Represents Global Labeling at Regulatory Satellite and strategy meetings.
• Provides input for carton/container artwork and collaborates on packaging labeling.
• Supports Health Authority inspections with labeling information.
• Manages SPL process with external vendors and confirms successful submissions.
• Leads continuous improvement of labeling processes.

Skills

Labeling strategy

Regulatory submissions

Cross-functional leadership

Project management

USPI / SmPC

SPL process

Global labeling

Regulatory Affairs

Strategic thinking

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Job description

Travere Therapeutics in San Diego is seeking an Associate Director, Labeling Strategy to lead global labeling across the product lifecycle. You will guide development of labeling content, coordinate with Regulatory Affairs, Clinical Development, and Legal, and drive alignment with Health Authority expectations.

The role requires extensive experience in USPI and EU SmPC labeling, strong project management, and ability to influence senior leadership.