Remote Associate Director, CMC Regulatory Affairs

Travere Therapeutics; Atlanta (GA); Remote; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Job summary

Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule CMC across development and commercialization. You will lead global submissions, liaise with Health Authorities, and guide cross-functional teams to ensure regulatory compliance across markets.

The role requires extensive CMC regulatory experience, a background in oral solid dosage forms, and the ability to travel up to 10% domestically and internationally.

Qualifications

• 8+ years of Regulatory Affairs experience with CMC.
• Strong experience with small molecule products from IND through commercialization.
• Experience with global regulatory submissions and Health Authority interactions.
• Willingness to travel up to 10% domestically and internationally.

Responsibilities

• Lead global CMC regulatory submissions and Health Authority interactions.
• Provide strategic regulatory leadership for CMC activities across development and commercialization.
• Collaborate with cross-functional teams (PDD, Manufacturing, QA, Analytical) to align on regulatory plans.
• Develop filing strategies for post-approval CMC changes and lifecycle management.
• Prepare, review, and submit Module 2 and Module 3 CMC documentation.

Skills

CMC Regulatory

Regulatory leadership

Cross-functional collaboration

Global submissions

Education

Bachelor's in Pharmaceutical Sciences

MS/PhD/PharmD preferred

Job description

Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for small molecule CMC across development and commercialization. You will lead global submissions, liaise with Health Authorities, and guide cross-functional teams to ensure regulatory compliance across markets.

The role requires extensive CMC regulatory experience, a background in oral solid dosage forms, and the ability to travel up to 10% domestically and internationally.