Associate Director, Global Labeling Strategy

Travere Therapeutics; Atlanta (GA); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director of Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will ensure accurate labeling (USPI, CCDS) and alignment with strategic goals, partnering with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality teams.

You will drive labeling strategy, manage cross-functional collaboration, and lead communications with Health Authorities.

Qualifications

• Bachelor's degree in a scientific discipline is required or equivalent experience.
• Advanced degree (MS/PhD/PharmD or equivalent) preferred.
• 8+ years in pharma/biotech with 6 years in labeling or regulatory-related work.
• Strong knowledge of US/EU labeling requirements (USPI and EU SmPC).

Responsibilities

• Leads labeling multi-disciplinary team (LWG) to align on strategy and content.
• Coordinates ELB approvals and labeling submissions.
• Authors TPL, CCDS, and USPI with inputs from cross-functional teams.
• Develops and executes global labeling implementation plans incorporating new data and Health Authority feedback.
• Manages CCDS and labeling communications for assigned products.
• Oversees timely Health Authority submissions and label negotiations across regions.
• Interprets regulatory guidance to ensure compliant labeling content.
• Ensures alignment of local labeling with CCDS across US, EU, and ROW.

Skills

Regulatory labeling

Project management

Cross-functional collaboration

Education

Bachelor's in science

Advanced degree preferred

Job description

Travere Therapeutics is seeking an Associate Director of Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will ensure accurate labeling (USPI, CCDS) and alignment with strategic goals, partnering with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality teams.

You will drive labeling strategy, manage cross-functional collaboration, and lead communications with Health Authorities.