Global Regulatory Labeling Strategy Lead (Remote)

Travere Therapeutics; Minneapolis (MN); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health insurance

Retirement plans

Paid time off

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, compliant labeling aligned with strategic goals and partner with regulatory, medical, legal, and commercial teams.

You will drive planning, content creation (TPL/CCDS/USPI), and negotiations with health authorities while overseeing cross-functional labeling projects and implementing updates promptly.

Qualifications

• Labeling strategy development and governance across product lifecycles.
• Strong knowledge of US/EU labeling standards (USPI, SmPC).
• Ability to lead cross-functional labeling initiatives with minimal supervision.

Responsibilities

• Lead Labeling Working Group to align on content and strategy.
• Coordinate ELB approvals and manage labeling timelines.
• Draft and review TPL, CCDS, and USPI with cross-functional input.
• Develop global labeling implementation plans incorporating new data.
• Provide strategic labeling guidance for regulatory submissions and post-market activities.
• Manage Health Authority interactions and deviations across regions.
• Mentor Local Labeling Leads and communicate with senior leadership.

Skills

Labeling strategy

Cross-functional leadership

Regulatory affairs

Project management

Communication skills

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred (MS/PhD/PharmD)

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, compliant labeling aligned with strategic goals and partner with regulatory, medical, legal, and commercial teams.

You will drive planning, content creation (TPL/CCDS/USPI), and negotiations with health authorities while overseeing cross-functional labeling projects and implementing updates promptly.