Global Labeling Strategy Lead

Travere Therapeutics; Washington (District of Columbia); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Company stock incentives

Generous paid time off

Job summary

Travere Therapeutics in San Diego, with remote options, seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. This role ensures accurate, compliant prescribing information and aligns labeling with company objectives.

The individual partners with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality to drive labeling development, negotiations, and implementation, including CCDS/USPI updates.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 8+ years in pharmaceutical/biotech with 6+ years labeling or regulatory experience.
• Strong knowledge of US/EU labeling requirements (USPI and EU SmPC).
• Ability to travel up to 10% domestically and internationally.

Responsibilities

• Lead Labeling multi-disciplinary team (LWG) to align on strategy and content.
• Coordinate ELB approvals for labeling reviews and updates.
• Author TPL, CCDS, and USPI with input from cross-functional teams.
• Develop global labeling plans to incorporate new data and regulatory feedback.
• Manage communications on CCDS and labeling updates for products.
• Provide strategic guidance to Local Labeling Leads and respond to health authorities.

Skills

Regulatory labeling strategy

Cross-functional collaboration

Project management

Strategic thinking

Communication

Regulatory judgment

Negotiations with health authorities

Education

Bachelor's degree in a scientific field

Advanced degree preferred (MS/PhD/PharmD)

Job description

Travere Therapeutics in San Diego, with remote options, seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. This role ensures accurate, compliant prescribing information and aligns labeling with company objectives.

The individual partners with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality to drive labeling development, negotiations, and implementation, including CCDS/USPI updates.