Global CMC Regulatory Lead — Small Molecule (Remote)

Travere Therapeutics; Kansas City (MO); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Wellness programs

Job summary

Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC across development and commercialization of small molecule drugs, with emphasis on oral solid dosage forms. You will lead global submissions, advise on regulatory strategy, and coordinate cross-functional teams.

Role requires 8+ years in regulatory affairs and experience with IND through NDA, plus interaction with major global regulators.

Qualifications

• 8+ years of Regulatory Affairs experience with strong CMC exposure.
• Experience with small molecule development from IND through commercialization.
• Experience interacting with FDA, EMA, GCC, and PMDA is preferred.

Responsibilities

• Lead global CMC regulatory submissions and Health Authority interactions.
• Develop and implement global CMC regulatory strategies across development and lifecycle management.
• Provide leadership on cross-functional teams to align regulatory plans with program goals.
• Oversee formulation development, process validation, and analytics support for CMC.
• Support inspections readiness and post-approval lifecycle management.

Skills

CMC regulatory leadership

Regulatory strategy

Cross-functional leadership

Global submissions

Oral solid dosage expertise

Education

Bachelor’s degree in Pharmaceutical Sciences or related

Advanced degree preferred

Job description

Travere Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC across development and commercialization of small molecule drugs, with emphasis on oral solid dosage forms. You will lead global submissions, advise on regulatory strategy, and coordinate cross-functional teams.

Role requires 8+ years in regulatory affairs and experience with IND through NDA, plus interaction with major global regulators.