CMC Regulatory Affairs Senior Manager - Small Molecules

Travere Therapeutics; Washington (District of Columbia); On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Total rewards package

Premium health benefits

Competitive compensation with stock

Job summary

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership across development and commercial programs, with emphasis on oral solid dosage forms. The role partners with Clinical, Manufacturing, Quality, Analytical Development, and Regulatory Operations to ensure compliant CMC development plans.

The ideal candidate has extensive experience from IND through NDA, strong leadership, and collaboration skills, and must be able to travel up to

Qualifications

• Bachelor's degree in pharmaceutical sciences or related required.
• Advanced degree (MS/PhD, PharmD) preferred.
• Experience leading CMC regulatory submissions from IND through post-approval.

Responsibilities

• Lead CMC regulatory strategies for development, submissions, and lifecycle management.
• Serve as primary CMC Regulatory lead on cross-functional teams.
• Coordinate with QA, Manufacturing, Analytical Development for regulatory alignment.
• Prepare and manage CMC documentation for regulatory submissions (INDs, NDAs, MAAs).
• Support regulatory inspections and health authority interactions.

Skills

CMC Regulatory Affairs

Regulatory strategy

Cross-functional collaboration

Small molecule expertise

Leadership

IND through NDA

Education

Bachelor's degree in Pharmaceutical Sciences or related

Advanced degree preferred (MS/PhD)

Job description

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to provide strategic regulatory leadership across development and commercial programs, with emphasis on oral solid dosage forms. The role partners with Clinical, Manufacturing, Quality, Analytical Development, and Regulatory Operations to ensure compliant CMC development plans.

The ideal candidate has extensive experience from IND through NDA, strong leadership, and collaboration skills, and must be able to travel up to