Associate Director, CMC Regulatory Affairs - Molecules

107000 Regulatory

San Diego, USA
- Remote

At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding - both professionally and personally - because we are making a difference. We are passionate about what we do.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission - to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

The Associate Director, CMC Regulatory Affairs is responsible for providing strategic and operational regulatory leadership for Chemistry, Manufacturing, and Controls (CMC) activities across development and commercial programs. This role leads the development and execution of CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for small molecule drug products, with primary emphasis on oral solid dosage forms including tablets and capsules.

The Associate Director serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with regulatory requirements and business objectives.

This position requires extensive experience supporting small molecule drug product development from IND through commercialization, with significant expertise in oral solid dosage forms, drug product manufacturing, formulation development, analytical methods, process validation, and lifecycle management.

The individual will be responsible for driving global CMC regulatory submissions, leading Health Authority interactions related to CMC topics, assessing regulatory risks, and supporting successful product approvals and post-approval activities across major global markets, including the United States (FDA), Europe (EMA), Gulf Cooperation Council (GCC) countries, and Japan (PMDA).

CMC Regulatory Strategy, Submissions & Dossier Development

• Develop and implement global 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 throughout product development and commercialization.
• Partner with Pharmaceutical Development, Technical Operations, Manufacturing, Quality, Analytical Development, Supply Chain, and Regulatory Operations to ensure CMC activities support regulatory objectives and submission timelines.
• Assess regulatory risks, develop mitigation strategies, and provide strategic regulatory recommendations to support program goals and business priorities.
• Provide regulatory support for products from IND through NDA approval and post-approval lifecycle management, including expedited development pathways where applicable.
• Lead preparation, review, and submission of…