Remote Senior CMC Regulatory Lead – Small Molecule

Travere Therapeutics; Providence (RI); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics in San Diego seeks Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for CMC activities across development and commercial programs, with emphasis on oral solid dosage forms.

You will lead global submissions, health authority interactions (FDA, EMA, PMDA), risk assessments, and lifecycle management, collaborating with Pharmaceutical Development, Manufacturing, Quality and Regulatory Operations to align CMC plans with

Qualifications

• 8+ years in Regulatory Affairs with CMC focus.
• Experience from IND through commercialization for small molecules.
• Strong background in oral solid dosage forms (tablets, capsules).

Responsibilities

• Lead global CMC regulatory submissions and health authority interactions.
• Develop and implement global CMC strategies for development and lifecycle.
• Collaborate with cross-functional teams to align regulatory plans with objectives.
• Provide regulatory guidance on API/excipients, formulation, process validation.
• Support manufacturing site transfers and post-approval changes.

Skills

CMC regulatory expertise

Regulatory leadership

Cross-functional collaboration

IND through NDA

Oral solids expertise

Education

Bachelor's degree in Pharmaceutical Sciences

MS/PhD or PharmD preferred

Job description

Travere Therapeutics in San Diego seeks Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for CMC activities across development and commercial programs, with emphasis on oral solid dosage forms.

You will lead global submissions, health authority interactions (FDA, EMA, PMDA), risk assessments, and lifecycle management, collaborating with Pharmaceutical Development, Manufacturing, Quality and Regulatory Operations to align CMC plans with