Associate Director, Global Labeling Strategy (Remote)

Travere Therapeutics; United States; On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Stock options

Comprehensive benefits

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle, ensuring USPI and CCDS content is accurate and compliant.

You will partner with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality to develop, negotiate, implement, and maintain labeling for submissions and post‑marketing activities. Travel up to 10% is required; the role is not 100% remote.

Qualifications

• Bachelor's degree in Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required.
• 8+ years of relevant pharmaceutical or biotech industry experience, including 6 years of direct labeling experience or 5+ years regulatory experience.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience).

Responsibilities

• Lead labeling strategy with cross-functional partners and a Labeling Working Group.
• Coordinate labeling approvals by the Executive Labeling Board (ELB) for applicable reviews.
• Author TPL, CCDS, and USPI for assigned products with input from all relevant functions.
• Develop and implement global labeling plans to incorporate new data and Health Authority feedback.
• Manage communications on CCDS and labeling updates and lead labeling negotiations with authorities.

Skills

Labeling strategy

Regulatory affairs

Cross-functional collaboration

Project management

Regulatory labeling

Education

Bachelor's degree in a scientific discipline

MS/PhD/PharmD preferred

Job description

Travere Therapeutics in San Diego, CA is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling across the product lifecycle, ensuring USPI and CCDS content is accurate and compliant.

You will partner with Regulatory Affairs, Clinical Development, Drug Safety, Medical Affairs, Commercial, Legal and Quality to develop, negotiate, implement, and maintain labeling for submissions and post‑marketing activities. Travel up to 10% is required; the role is not 100% remote.