Department: 107000 Regulatory

Location: San Diego, USA- Remote

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease.

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.

Position Summary: The Senior Director, Regulatory Affairs CMC will be responsible for the global management and leadership of regulatory activities relating to global chemistry, manufacturing and controls (CMC/Quality) regulatory affairs function. This role is responsible for defining and executing global regulatory affairs CMC strategies pertaining to the development, registration and regulatory compliance of Travere Therapeutics, Inc. products in the United States, European Union, Asia Pacific and Latin America. This includes interacting with the FDA, EMA and national Regulatory Agencies in the EU Member States and other health authorities as needed to ensure timely submission, approval and maintenance of company products.

Responsibilities:

• Define and execute the global CMC/quality regulatory strategy for Travere Therapeutics, Inc. products including maintaining and extending product registrations in United States, European Union, Asia Pacific and Latin America markets.
• Designs global CMC/quality regulatory strategies in close collaboration with GRL to obtain, maintain and extend product registrations in US, Europe and ROW.
• Provide regional global CMC/quality regulatory expertise and work in collaboration with the GRL in organizing and providing support to meetings Health Authorities.
• Provide global regulatory strategic insight and regulatory procedural expertise in line with applicable directives and regulatory guidelines.
• Partner with global CMC/Quality regulatory stakeholders on strategies for Travere Therapeutics, Inc. investigational and licensed products in all applicable regions, including but not limited to United States, European Union, Asia Pacific and Latin America.
• Collaborate closely with internal regulatory stakeholders (Strategy/Development, CMC, Labeling, and Operations) and regulatory staff at vendor and partner companies to ensure that all aspects of regulatory strategies are coordinated and considered.
• Assure accurate and timely compilation and submission of regulatory documentation.
• Lead the Travere Therapeutics, Inc. Global CMC/Quality Regulatory function by providing direction, guidance, and mentorship to direct reports.
• Represent Travere Therapeutics, Inc. Regulatory Affairs in Travere Therapeutics, Inc. global CMC/quality matters and operations.
• Direct and lead cross-functional submission teams to ensure creation and submission of global CMC/quality regulatory documents (NDA, MAA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as... For full info follow application link.

Travere Therapeutics, Inc. is an EEO/AA/Veteran/Disabilit y Employer