Senior CMC Regulatory Lead – Small Molecules (Remote)

Travere Therapeutics; Oklahoma City (OK); Remote; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Financial wellbeing programs

Generous paid time off

Job summary

Travere Therapeutics in San Diego seeks a senior CMC Regulatory Affairs leader to drive global regulatory strategies for small molecule products, from IND through lifecycle management. You will lead cross-functional teams, prepare submissions, and interact with Health Authorities worldwide, including FDA, EMA, GCC, and PMDA.

Travel up to 10% domestically and internationally. Strong experience with oral solid dosage forms and lifecycle management is required; advanced degrees are preferred.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or related field is required.
• Advanced degree preferred (MS/PhD/PharmD).
• 8+ years Regulatory Affairs experience in pharma/biotech with CMC focus.

Responsibilities

• Lead global CMC regulatory submissions (INDs, CTAs, NDAs, MAAs, variations).
• Serve as CMC regulatory lead on cross-functional programs.
• Coordinate regulatory strategy, risk assessment, and Health Authority interactions.
• Ensure compliance of Module 2/3 CMC documentation with global requirements.
• Support post-approval CMC changes and lifecycle management.

Skills

CMC Strategy

Regulatory Leadership

Global Submissions

Health Authority Interactions

Cross-Functional Collaboration

Education

Bachelor's in Pharmaceutical Sciences

MS/PhD/PharmD preferred

Job description

Travere Therapeutics in San Diego seeks a senior CMC Regulatory Affairs leader to drive global regulatory strategies for small molecule products, from IND through lifecycle management. You will lead cross-functional teams, prepare submissions, and interact with Health Authorities worldwide, including FDA, EMA, GCC, and PMDA.

Travel up to 10% domestically and internationally. Strong experience with oral solid dosage forms and lifecycle management is required; advanced degrees are preferred.