Global Labeling Strategy Lead

Travere Therapeutics; Manchester (NH); Hybrid; 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. You will partner with Regulatory Affairs, Clinical Development, Medical Affairs, Legal, and Quality to shape labeling and ensure accuracy and compliance.

You will author and manage CCDS, USPI, and labeling updates, coordinate with ELB, and drive timely submissions while aligning with global health authority expectations.

Qualifications

• Bachelor's degree in biology, chemistry, or related field required.
• Advanced degree preferred (MS/PhD/PharmD).
• 8+ years in pharma/biotech with 6+ years in labeling or regulatory roles.
• Strong knowledge of US/EU labeling requirements (USPI/EU SmPC).

Responsibilities

• Leads Labeling Working Group to align on strategy and content.
• Authors CCDS/TP L/USPI for assigned products with cross-functional input.
• Develops and executes global labeling implementation plans.
• Interprets regulations and ensures labeling content meets regulatory requirements.

Skills

Project management

Cross-functional collaboration

Regulatory judgment

Strategic thinking

Excellent communication

Travel readiness

Education

Bachelor's degree in science

Advanced degree preferred (MS/PhD/ PharmD)

Tools

SPL process

USPI/EU SmPC knowledge

Job description

Travere Therapeutics is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will partner with Regulatory Affairs, Clinical Development, Medical Affairs, Legal, and Quality to shape labeling and ensure accuracy and compliance.

You will author and manage CCDS, USPI, and labeling updates, coordinate with ELB, and drive timely submissions while aligning with global health authority expectations.