Director, Global Labeling Strategy (Remote)

Travere Therapeutics; Columbus (OH); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Wellness programs

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across product lifecycle. You will guide USPI, CCDS and labeling updates, collaborating with Regulatory, Clinical Development, Medical Affairs, Legal and Quality to ensure compliant, evidence-based labeling.

In this role you will lead the Labeling Working Group, drive ELB approvals, author CCDS/USPI, and align local labeling with CCDS while managing risk and timelines.

Qualifications

• BS in a scientific discipline required; advanced degree preferred.
• 8+ years in pharma/biotech with labeling experience.
• Strong knowledge of US and EU labeling requirements (USPI/EU SmPC).

Responsibilities

• Lead labeling multi-disciplinary team (Labeling Working Group).
• Coordinate ELB approvals and cross-functional input.
• Author TPL, CCDS, and USPI with annotations.
• Develop and implement global labeling plans with new data and Health Authority responses.
• Manage CCDS updates and labeling communications with stakeholders.
• Drive timely Health Authority submissions and label negotiations.
• Interpret regulatory guidance and ensure compliant labeling content.
• Align local labeling with CCDS across regions; assess deviations.
• Advise Local Labeling Leads on health authority responses.
• Present labeling issues to Executive Labeling Board for decisions.
• Analyze competitor labeling and trends to inform strategy.
• Represent Global Labeling in regulatory meetings and collaborations.
• Contribute to packaging labeling artwork with Technical Operations.
• Support inspections with labeling information requests.
• Lead SPL process with external vendors and submissions.

Skills

Labeling strategy

Regulatory labeling

Project management

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in a scientific discipline

Advanced degree (MS/PhD/PharmD)

Job description

Travere Therapeutics seeks an Associate Director, Labeling Strategy to lead global regulatory labeling across product lifecycle. You will guide USPI, CCDS and labeling updates, collaborating with Regulatory, Clinical Development, Medical Affairs, Legal and Quality to ensure compliant, evidence-based labeling.

In this role you will lead the Labeling Working Group, drive ELB approvals, author CCDS/USPI, and align local labeling with CCDS while managing risk and timelines.