Associate Director, CMC Regulatory Affairs – Remote

Travere Therapeutics; Manchester (NH); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for CMC activities across development and commercial programs, focusing on oral solid dosage forms.

You will lead global CMC submissions, interact with Health Authorities, ensure compliance and lifecycle management, and collaborate with Regulatory, Manufacturing, Quality, and Development teams to align CMC strategies with business objectives.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field.
• Advanced degree (MS/PhD/PharmD) preferred.
• 8+ years regulatory affairs experience with CMC focus.
• Strong experience with small molecule products from IND through commercialization.

Responsibilities

• Lead global CMC regulatory submissions for INDs, NDAs, and variations.
• Act as primary CMC regulatory lead on cross-functional teams.
• Interact with Health Authorities (FDA/EMA/PMDA) on CMC topics.
• Ensure alignment of CMC development plans with regulatory requirements.
• Support post-approval lifecycle changes and site transfers.

Skills

CMC Regulatory

Regulatory Strategy

Global Submissions

Health Authority Interactions

Leadership

Education

Bachelor's degree in Pharmaceutical Sciences or related field

MS/PhD/PharmD preferred

Job description

Travere Therapeutics in San Diego, CA is seeking an Associate Director, CMC Regulatory Affairs to provide strategic and operational regulatory leadership for CMC activities across development and commercial programs, focusing on oral solid dosage forms.

You will lead global CMC submissions, interact with Health Authorities, ensure compliance and lifecycle management, and collaborate with Regulatory, Manufacturing, Quality, and Development teams to align CMC strategies with business objectives.