Remote Global Labeling Strategy Lead

Travere Therapeutics; Columbia (SC); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Well-being offerings

Life insurance

Disability insurance

Retirement plan with employer match

Generous paid time off

Job summary

You will drive authoring of TPL, CCDS, and USPI, implement labeling plans, and oversee negotiations with health authorities. This role requires 8+ years in pharma, strong project management, and travel readiness.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 8+ years in pharma/biotech with 6+ years in labeling or regulatory roles.
• Strong knowledge of US/EU labeling requirements (USPI and EU SmPC).

Responsibilities

• Lead cross-functional Labeling Working Group to align labeling strategy.
• Coordinate ELB approvals and labeling negotiations.
• Author TPL, CCDS, and USPI with input from functions.
• Develop global labeling implementation plans with regulatory and safety inputs.
• Provide strategic labeling guidance for development, submissions, and post-marketing.
• Ensure regulatory compliance across US, EU, and ROW.

Skills

Project management

Cross-functional collaboration

Regulatory labeling knowledge

Regulatory submissions

Communication skills

Travel ability

Education

Bachelor's degree in a scientific discipline

MS/PhD/PharmD or equivalent

Tools

SPL process

Job description

You will drive authoring of TPL, CCDS, and USPI, implement labeling plans, and oversee negotiations with health authorities. This role requires 8+ years in pharma, strong project management, and travel readiness.