Senior CMC Regulatory Lead (Small Molecules) – Remote

Travere Therapeutics; Minneapolis (MN); On-site; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics, based in San Diego, seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for small molecule products from IND through NDA and post-approval lifecycle. You will coordinate cross-functional teams, prepare regulatory submissions, and interact with health authorities worldwide, including FDA, EMA, GCC, and PMDA.

The role emphasizes oral solid dosage forms, manufacturing, quality, and lifecycle management.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or related field required.
• Advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• 8+ years of Regulatory Affairs experience with significant CMC experience.

Responsibilities

• Lead global CMC regulatory submissions and Health Authority interactions.
• Provide regulatory leadership on cross-functional teams across development and commercialization.
• Develop and implement CMC strategies for small molecule products (oral solids).
• Mentor and guide teams to ensure timely regulatory deliverables and lifecycle activities.
• Coordinate submissions (INDs, CTAs, NDAs, MAAs, variations) and respond to regulatory questions.

Skills

Regulatory leadership

CMC regulatory

Cross-functional collaboration

Education

Bachelor's in Pharmaceutical Sciences/related

Advanced degree preferred

Job description

Travere Therapeutics, based in San Diego, seeks an Associate Director, CMC Regulatory Affairs to lead global regulatory strategies for small molecule products from IND through NDA and post-approval lifecycle. You will coordinate cross-functional teams, prepare regulatory submissions, and interact with health authorities worldwide, including FDA, EMA, GCC, and PMDA.

The role emphasizes oral solid dosage forms, manufacturing, quality, and lifecycle management.