Associate Director, CMC Regulatory Affairs — Global Impact

Travere Therapeutics; San Diego (CA); Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits

Job summary

Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs in San Diego, with remote flexibility. You will lead global CMC strategies, author Module 2/3 documentation, and drive interactions with Health Authorities through INDs, NDAs, and lifecycle changes for small molecule products.

The role requires 8+ years in Regulatory Affairs focused on CMC, with strong collaboration across Regulatory, Development, Manufacturing and Quality to ensure compliant, timely submissions and

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or related field; advanced degree preferred.
• 8+ years of Regulatory Affairs experience with CMC focus.
• Experience from IND through commercialization for small molecules.
• Strong collaboration with cross-functional teams and external partners.

Responsibilities

• Lead global CMC regulatory submissions and Health Authority interactions.
• Provide strategic regulatory guidance for oral solid dosage products.
• Coordinate cross-functional contributions to regulatory filings and timelines.
• Maintain inspection readiness and lifecycle management activities.

Skills

Regulatory strategy

CMC regulatory submissions

Cross-functional leadership

Small molecule development

FDA/EMA/PMDA experience

Education

Bachelor's in Pharmaceutical Sciences or related field

Advanced degree preferred (MS/PhD/PharmD)

Tools

INDs/NDA submissions tools

Job description

Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs in San Diego, with remote flexibility. You will lead global CMC strategies, author Module 2/3 documentation, and drive interactions with Health Authorities through INDs, NDAs, and lifecycle changes for small molecule products.

The role requires 8+ years in Regulatory Affairs focused on CMC, with strong collaboration across Regulatory, Development, Manufacturing and Quality to ensure compliant, timely submissions and