Remote Global Labeling Strategy Lead

Travere Therapeutics; Kansas City (MO); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will develop, negotiate, implement and maintain labeling content including USPI, CCDS, and TPL, collaborating with Regulatory, Clinical Development, Medical Affairs and Legal.

This role requires 8+ years in pharma/biotech, strong leadership, and a track record in global labeling strategy, with readiness to travel up to 10% domestically and

Qualifications

• Bachelor's degree in biology, chemistry, or related field required; advanced degree preferred.
• 8+ years in pharma/biotech with 6+ years labeling/regulatory exposure.
• Strong knowledge of US/EU labeling requirements (USPI and EU SmPC).

Responsibilities

• Lead Labeling multi-disciplinary team (LWG) across global programs.
• Coordinate labeling approvals with Executive Labeling Board (ELB).
• Author and update TPL, CCDS, and USPI for assigned products with cross-functional input.
• Develop global labeling implementation plans incorporating new data and Health Authority responses.
• Provide strategic direction on labeling for development, regulatory submissions, and post-marketing.
• Manage international labeling alignment (US/EU/ROW).

Skills

Cross-functional collaboration

Project management

Regulatory knowledge

Communication skills

Travel readiness

Matrixed collaboration

Education

Bachelor's degree in science

Advanced degree (MS/PhD/PharmD)

Tools

SPL process

USPI/SmPC familiarity

Job description

Travere Therapeutics in San Diego seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will develop, negotiate, implement and maintain labeling content including USPI, CCDS, and TPL, collaborating with Regulatory, Clinical Development, Medical Affairs and Legal.

This role requires 8+ years in pharma/biotech, strong leadership, and a track record in global labeling strategy, with readiness to travel up to 10% domestically and