Senior Global Labeling Strategy Lead (Remote)

Travere Therapeutics; Denver (CO); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics seeks an Associate Director of Labeling Strategy to lead global regulatory labeling throughout the product lifecycle. This role heads the labeling lead for development and commercial products, ensuring accurate, compliant prescribing information and patient labeling aligned with strategic objectives.

You will collaborate with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal, and Quality to develop, negotiate, implement, and maintain

Qualifications

• Bachelor's degree in a scientific discipline required (e.g., Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering).
• Advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• 8+ years in pharma/biotech with 6+ years in labeling or regulatory roles; strong US/EU labeling knowledge (USPI/EU SmPC).

Responsibilities

• Lead Labeling multi-disciplinary team (LWG) to align labeling strategy and content.
• Coordinate ELB approvals for labeling decisions.
• Author TS/USPI/CCDS and manage annotations with stakeholders.

Skills

Labeling strategy

Cross-functional leadership

Project management

Regulatory strategy

Communication

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Travere Therapeutics seeks an Associate Director of Labeling Strategy to lead global regulatory labeling throughout the product lifecycle. This role heads the labeling lead for development and commercial products, ensuring accurate, compliant prescribing information and patient labeling aligned with strategic objectives.

You will collaborate with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal, and Quality to develop, negotiate, implement, and maintain