Senior Global Labeling Strategy Lead – Remote

Travere Therapeutics; San Diego (CA); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plan with employer match

Generous paid time off

Job summary

Travere Therapeutics seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will ensure accurate, compliant prescribing and patient labeling, coordinating with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality.

You will drive labeling negotiations with Health Authorities, develop CCDS/USPI content, and manage international labeling alignment while maintaining timelines and regulatory

Qualifications

• Bachelor's degree in a scientific discipline required.
• 8+ years of pharmaceutical or biotech labeling experience.
• Strong knowledge of US/EU labeling requirements and guidelines.

Responsibilities

• Lead cross-functional Labeling Working Group to align labeling strategy and content.
• Coordinate approval processes with Executive Labeling Board.
• Author CCDS, USPI and labeling updates with input from relevant functions.

Skills

Regulatory labeling

Project management

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

Travere Therapeutics seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will ensure accurate, compliant prescribing and patient labeling, coordinating with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality.

You will drive labeling negotiations with Health Authorities, develop CCDS/USPI content, and manage international labeling alignment while maintaining timelines and regulatory