Remote Associate Director, CMC Regulatory Affairs (Small Molecules)

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

Benefits offered by this job

Stock-based compensation

Comprehensive benefits

Job summary

Travere Therapeutics in San Diego seeks a senior CMC Regulatory Director to lead global regulatory strategies for small molecule products. You will drive submissions from IND to NDA, coordinate cross-functional teams, and manage lifecycle activities across major markets including the US, Europe, GCC, and Japan.

Experience with oral solid dosage forms and a proven track record in Health Authority engagements is required.

Qualifications

• 8+ years of Regulatory Affairs experience with strong CMC background.
• Experience from IND through commercialization and post-approval lifecycle.
• Experience preparing global CMC submissions (INDs, CTAs, NDAs, MAAs, variations).
• Ability to lead Health Authority interactions and risk assessments in global markets.

Responsibilities

• Lead global CMC regulatory strategies to support development, registration, and lifecycle management.
• Serve as CMC regulatory lead on cross-functional teams and provide strategic guidance.
• Coordinate contributions to global CMC submissions and ensure regulatory alignment.
• Lead preparation and submission of CMC documentation for regulatory filings.
• Provide regulatory oversight for analytical method development, validation, and stability.

Skills

Regulatory leadership

CMC regulatory affairs

Small molecule drugs

FDA/EMA/PMDA experience

Cross-functional collaboration

Regulatory submissions

Education

Bachelor's degree in Pharmaceutical Sciences or related

Advanced degree preferred

Job description

Travere Therapeutics in San Diego seeks a senior CMC Regulatory Director to lead global regulatory strategies for small molecule products. You will drive submissions from IND to NDA, coordinate cross-functional teams, and manage lifecycle activities across major markets including the US, Europe, GCC, and Japan.

Experience with oral solid dosage forms and a proven track record in Health Authority engagements is required.