Senior CMC Regulatory Lead – Remote (Small Molecules)

Travere Therapeutics; Kansas City (MO); On-site; USD 132,000 - 172,000; Full time

Benefits offered by this job

Premium health benefits

Retirement plan with employer match

Generous paid time off

Job summary

Travere Therapeutics seeks a Senior Manager of CMC Regulatory Affairs to lead strategic regulatory activities for small molecule products, from IND through NDA and lifecycle management. The role collaborates with Pharmaceutical Development, Manufacturing, Quality, Analytical Development, and Regulatory Operations to align CMC plans with regulatory requirements.

The position emphasizes oral solid dosage forms, process validation, analytical methods, and cross-functional teamwork to ensure timely

Qualifications

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

Responsibilities

• Develop and implement CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of small molecule products.
• Serve as the CMC Regulatory lead on cross-functional program teams, providing strategic regulatory guidance throughout product development and commercialization.
• Coordinate with regulatory operations to ensure timely submissions and alignment with regulatory expectations.
• Lead preparation, review, and submission of CMC documentation for INDs, CTAs, NDAs, MAAs, amendments, and variations.
• Support inspection readiness and regulatory assessments related to manufacturing and product quality.

Skills

CMC Regulatory Strategy

Regulatory Submissions

Cross-functional Leadership

Health Authority Interactions

Oral Solid Dosage Forms

IND to NDA Lifecycle

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or related

Advanced degree (MS, PhD, PharmD) preferred

Job description

Travere Therapeutics seeks a Senior Manager of CMC Regulatory Affairs to lead strategic regulatory activities for small molecule products, from IND through NDA and lifecycle management. The role collaborates with Pharmaceutical Development, Manufacturing, Quality, Analytical Development, and Regulatory Operations to align CMC plans with regulatory requirements.

The position emphasizes oral solid dosage forms, process validation, analytical methods, and cross-functional teamwork to ensure timely