Global Labeling Strategy Lead

Travere Therapeutics; Detroit (MI); Remote; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. This role partners with Regulatory Affairs, Clinical Development, Medical, and Legal to ensure accurate, compliant labeling aligned with strategic objectives.

The ideal candidate will drive the development and negotiation of labeling content for TPL, CCDS, and USPI, coordinate ELB approvals, and manage cross‑functional labeling programs to meet Health

Qualifications

• Bachelor's degree in a scientific discipline is required. An advanced degree is preferred.
• 8+ years in pharma/biotech with 6+ years labeling or regulatory experience.
• Strong knowledge of US/EU labeling requirements, including USPI and EU SmPC.

Responsibilities

• Lead global labeling strategy as the primary labeling lead for development and commercial products.
• Coordinate ELB reviews and cross-functional alignment on labeling content.
• Author and maintain TPL, CCDS, and USPI with input from functional teams.
• Develop and execute global labeling implementation plans incorporating new data and Health Authority feedback.
• Guide Local Labeling Leads and manage deviations for US, EU, and ROW.
• Provide strategic direction and communications regarding CCDS and labeling updates.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge

Communication skills

Travel willingness

Education

Bachelor's degree in sciences

MS/PhD/PharmD preferred

Tools

SPL process

CCDS/USPI labeling workflows

Job description

Travere Therapeutics is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. This role partners with Regulatory Affairs, Clinical Development, Medical, and Legal to ensure accurate, compliant labeling aligned with strategic objectives.

The ideal candidate will drive the development and negotiation of labeling content for TPL, CCDS, and USPI, coordinate ELB approvals, and manage cross‑functional labeling programs to meet Health