Global Labeling Strategy Lead – Associate Director (Remote)

Travere Therapeutics; Northern, San Diego (KY, CA); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego (US- Remote) is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will drive development and negotiation of labeling content (USPI, CCDS, TPL) and coordinate with Regulatory, Clinical, and Commercial teams.

The role requires expert knowledge of US and EU labeling requirements, strong project management, and the ability to influence senior stakeholders.

Qualifications

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

Responsibilities

• Lead labeling multi-disciplinary team (Labeling Working Group) to align on strategy and content.
• Coordinate labeling approval processes with Executive Labeling Board.
• Author and revise TPL, CCDS, and USPI with input from relevant functions.
• Develop global labeling implementation plans incorporating new data and health authority responses.
• Manage communications regarding CCDS and labeling updates for assigned products.
• Provide strategic direction to Local Labeling Leads for health authority responses and negotiations.
• Analyze competitor labeling and regulatory guidance to shape labeling strategy.

Skills

Labeling strategy

Regulatory submissions

Cross-functional leadership

Project management

Communication

Education

Bachelor's degree in science

MS/PhD preferred

Job description

Travere Therapeutics in San Diego (US- Remote) is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle. You will drive development and negotiation of labeling content (USPI, CCDS, TPL) and coordinate with Regulatory, Clinical, and Commercial teams.

The role requires expert knowledge of US and EU labeling requirements, strong project management, and the ability to influence senior stakeholders.