Remote Senior CMC Regulatory Lead - Small Molecules

Travere Therapeutics; Des Moines (IA); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities across development and commercial programs. The role emphasizes oral solid dosage forms and collaboration with multiple functional areas to ensure alignment with regulatory requirements.

The ideal candidate will have extensive experience with IND through NDA, global submissions, and Health Authority interactions, and must be able to travel up to 10%

Qualifications

• 8+ years Regulatory Affairs experience in pharma/biotech.
• Strong experience with small molecule products from IND through commercialization.
• Experience leading global CMC submissions and health authority interactions.
• Ability to travel 10% domestically and internationally.
• Onsite in San Diego; no role is expected to be 100% remote.

Responsibilities

• Lead global CMC regulatory submissions and Health Authority interactions.
• Develop and implement regulatory strategies for clinical development and commercialization.
• Collaborate with cross-functional teams to align regulatory plans with business objectives.
• Provide regulatory risk assessments and mitigation strategies throughout product lifecycle.
• Support inspections readiness and regulatory assessments related to manufacturing and quality.

Skills

Regulatory leadership

Cross-functional collaboration

Global regulatory submissions

Oral solid dosage experience

Education

Bachelor's degree in Pharmaceutical Sciences or related

Advanced degree preferred

Tools

INDs/NDAs/MAAs submissions

FDA/EMA/PMDA knowledge

Job description

Travere Therapeutics is seeking an Associate Director of CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities across development and commercial programs. The role emphasizes oral solid dosage forms and collaboration with multiple functional areas to ensure alignment with regulatory requirements.

The ideal candidate will have extensive experience with IND through NDA, global submissions, and Health Authority interactions, and must be able to travel up to 10%