Senior CMC Regulatory Lead, Small Molecules

Travere Therapeutics; Wichita (KS); Remote; USD 150,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Stock options

Competitive compensation

Job summary

Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities across development and commercialization. This role will drive global submissions, lead Health Authority interactions, and ensure lifecycle management across major markets, including FDA, EMA, GCC, and PMDA.

The position requires extensive experience in small molecule regulatory affairs, with emphasis on oral solid dosage forms, formulation development, and

Qualifications

• 8+ years of Regulatory Affairs experience with CMC focus.
• Experience from IND through commercialization for small molecules.
• Knowledge of global regulatory authorities (FDA, EMA, PMDA, GCC).

Responsibilities

• Develop global CMC regulatory strategies for clinical development and commercialization.
• Lead cross-functional teams on CMC submissions (INDs, NDAs, MAAs) and responses.
• Manage Health Authority meetings and post-approval lifecycle activities.
• Ensure readiness for inspections and regulatory assessments.

Skills

CMC regulatory leadership

Global regulatory submissions

Health Authority interactions

Oral solid dosage forms

Cross-functional collaboration

Education

Bachelor's degree in Pharmaceutical Sciences / related

MS/PhD/PharmD preferred

Job description

Travere Therapeutics is seeking an Associate Director, CMC Regulatory Affairs to provide strategic regulatory leadership for CMC activities across development and commercialization. This role will drive global submissions, lead Health Authority interactions, and ensure lifecycle management across major markets, including FDA, EMA, GCC, and PMDA.

The position requires extensive experience in small molecule regulatory affairs, with emphasis on oral solid dosage forms, formulation development, and