Remote Global Regulatory Labeling Strategy Lead

Travere Therapeutics; New York (NY); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Financial and retirement plans

Wellness programs

Generous paid time off

Job summary

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling efforts across product lifecycles.

You will partner with Regulatory Affairs, Clinical Development, Medical Affairs, and Legal to develop, negotiate, and implement labeling strategies, ensure USPI/EU SmPC compliance, and manage cross-functional discussions with Health Authorities.

Qualifications

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

Responsibilities

• Lead Labeling multi-disciplinary team (LWG) and drive cross-functional alignment on labeling strategy.
• Coordinate labeling approval processes with Executive Labeling Board (ELB).
• Author CCDS, USPI, and Tcl/TTPL documents for assigned products with input from multiple functions.
• Develop and execute global labeling implementation plans for new data and health authority responses.
• Manage communications regarding CCDS and labeling updates across products.
• Provide strategic direction to Local Labeling Leads for health authority responses and negotiations.

Skills

Project management

Cross-functional collaboration

Regulatory labeling knowledge

Strategic thinking

Education

Bachelor's degree in scientific field

Advanced degree preferred

Job description

Travere Therapeutics, a biopharmaceutical company focused on rare diseases, is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling efforts across product lifecycles.

You will partner with Regulatory Affairs, Clinical Development, Medical Affairs, and Legal to develop, negotiate, and implement labeling strategies, ensure USPI/EU SmPC compliance, and manage cross-functional discussions with Health Authorities.