Senior Manager, CMC Regulatory Affairs – Remote

Travere Therapeutics; Wichita (KS); On-site; USD 132,000 - 172,000; Full time

Job summary

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead regulatory strategies for small molecule products, focusing on oral solid dosage forms. You will work with cross-functional teams to align development plans with regulatory expectations and global submission timelines.

The role requires 7+ years in Regulatory Affairs with CMC expertise, experience from IND to NDA, and strong collaboration with development, manufacturing, and quality groups.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or a related scientific discipline required.
• Advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• 7+ years of Regulatory Affairs experience with significant CMC experience.
• Strong experience with small molecule products from IND through commercialization and post-approval lifecycle management.
• Experience supporting global regulatory activities with FDA, EMA, GCC, PMDA.
• Ability to travel 10% domestically and internationally.

Responsibilities

• Develop and implement CMC regulatory strategies to support clinical development, registration, commercialization, and lifecycle management of small molecule pharmaceutical products.
• Serve as the CMC Regulatory lead on cross-functional program teams, providing strategic regulatory guidance.
• Coordinate with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, and Regulatory Operations to ensure timely CMC activities.
• Lead preparation, review, and submission of CMC documentation for regulatory filings (INDs, CTAs, IMPDs, NDAs, MAAs, amendments, supplements, variations, annual reports).
• Author and review Module 2 and Module 3 CMC documentation for accuracy and regulatory compliance.
• Support inspection readiness and regulatory assessments related to manufacturing, quality systems, and product quality.
• Travel up to 10% domestically and internationally.

Skills

Regulatory strategy

Cross-functional leadership

CMC regulatory leadership

Oral solids expertise

IND-to-NDA experience

Global regulatory submissions

Risk assessment & mitigation

Education

Bachelor's in Pharmaceutical Sciences/related

Advanced degree preferred

Job description

Travere Therapeutics is seeking a Senior Manager, CMC Regulatory Affairs to lead regulatory strategies for small molecule products, focusing on oral solid dosage forms. You will work with cross-functional teams to align development plans with regulatory expectations and global submission timelines.

The role requires 7+ years in Regulatory Affairs with CMC expertise, experience from IND to NDA, and strong collaboration with development, manufacturing, and quality groups.