Senior CMC Regulatory Lead – Small Molecules (Remote)

Travere Therapeutics; Columbia (SC); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule programs, focusing on oral solid dosage forms. You will guide global CMC submissions, coordinate Health Authority interactions, and align development with regulatory requirements.

The role requires 8+ years in Regulatory Affairs, IND through NDA experience, and strong cross‑functional leadership to enable timely approvals and lifecycle management

Qualifications

• 8+ years of Regulatory Affairs experience with significant CMC experience.
• Experience from IND through commercialization and post-approval lifecycle management.
• Strong collaboration and leadership across cross-functional teams.

Responsibilities

• Lead global CMC regulatory submissions and Health Authority interactions.
• Develop and implement CMC regulatory strategies across development and lifecycle.
• Coordinate cross-functional contributions to regulatory filings and timelines.
• Assess regulatory risks and provide strategic recommendations to senior management.
• Support manufacturing changes, site transfers, and lifecycle management activities.

Skills

CMC Regulatory Strategy

Global Regulatory Submissions

Cross-functional Leadership

Health Authority Interactions

Regulatory Project Management

Education

Bachelor's degree in Pharmaceutical Sciences or related

Advanced degree preferred

Tools

Regulatory submissions tools

Documentation management systems

Job description

Travere Therapeutics in San Diego seeks an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule programs, focusing on oral solid dosage forms. You will guide global CMC submissions, coordinate Health Authority interactions, and align development with regulatory requirements.

The role requires 8+ years in Regulatory Affairs, IND through NDA experience, and strong cross‑functional leadership to enable timely approvals and lifecycle management