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

Life insurance

Disability

Retirement match

Paid time off

Well-being programs

Job summary

Travere Therapeutics, in San Diego, seeks an Associate Director of Labeling Strategy to lead global labeling across product lifecycles. You will partner with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal, and Quality to ensure accurate, compliant labeling aligned with company goals.

You will author CCDS/USPI, drive ELB approvals, manage labeling deviations across US/EU/ROW, and influence strategy with Health Authorities. Occasional travel is required.

Qualifications

• Bachelor’s degree in Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or related field required.
• 8+ years of pharmaceutical/biotech experience with 6+ years in labeling or regulatory roles.
• Strong knowledge of US/EU labeling regulations and guidelines (USPI and EU SmPC).

Responsibilities

• Lead Labeling Working Group (LWG) and coordinate cross-functional labeling efforts.
• Author and maintain CCDS, USPI, and labeling content for products.
• Develop global labeling implementation plans and ensure regulatory alignment across regions.

Skills

Regulatory labeling

Cross-functional leadership

US/EU labeling requirements

Project management

Strategic thinking

Education

Bachelor’s degree in a scientific field

Advanced degree preferred (MS/PhD/PharmD)

Tools

Structured Product Label (SPL)

Job description

Travere Therapeutics, in San Diego, seeks an Associate Director of Labeling Strategy to lead global labeling across product lifecycles. You will partner with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal, and Quality to ensure accurate, compliant labeling aligned with company goals.

You will author CCDS/USPI, drive ELB approvals, manage labeling deviations across US/EU/ROW, and influence strategy with Health Authorities. Occasional travel is required.