Senior Director, Global Labeling Regulatory Affairs

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, Global labeling Regulatory Affairs is responsible for leading the development of global labeling for clinical and commercial labeling materials across the product portfolio for Travere products. In this role, the Senior Director role requires a solid understanding of global labeling requirements, labeling platforms, label tracking, change control, and print production processes to effectively manage end-to-end label creation and implementation. This role will work collaboratively across various functions including Regulatory Affairs, Clinical Development, CMC, Clinical Pharmacology, Clinical Supply (CS), Medical Affairs/Medical Information, Medical Writing, Pharmacovigilance, Quality Assurance (QA), and legal as well as external vendors (as required) to ensure appropriate content and quality control checks are proceduralized and implemented for all labeling activities including Company Core Data Sheets (CCDS), Structured Product Labeling (SPL), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), Instructions for use (IFUs), medication guides, annotated labels and their associated Patient Labeling Documents to support initial Marketing Authorization and lifecycle updates (e.g., new indications, efficacy data, product quality changes and safety related information topics).

Responsibilities:

• Direct and ensure effective execution of optimal strategies for labeling development by providing global labeling insight, developing and implementing harmonized labeling processes for new product labels and associated life-cycle activities, and tracking/maintaining labeling documents.
• Ensure applicable global regulatory and compliance requirements are met and appropriately incorporated into all programs.

• Chair and drive label development for global labeling via the cross functional Label Working Group. Identify associated risks, develop risk mitigation strategies, and communicate project team decisions and project status. Apply influence and negotiation skills to support optimal label development.

• Oversee the prioritization, development, revision and approval of clinical supply labeling (e.g., active, placebos and standard of care drugs) in various countries to support the clinical pipeline.
• Serve as a strategic cross-functional partner collaborating with the CMO/CRO labeling specialists, and cross-functional project teams.
• Design, implement and maintain document tracking, history, versioning for labeling documents (including labeling project tracking tools and dashboards to monitor) and appropriate label archives across assigned projects and sites.
• Establish and maintain global strategic consistency across regional regulatory submissions.
• Oversight and accountability for labeling activities managed by external vendors, ensuring coordination and timely delivery.
• Present to cross-functional product teams and governance committees including executive level management to obtain endorsement, as appropriate, for the proposed labeling text.
• Ensure accurate and timely compilation and submission of all labeling documentation. Support responses to Health Authority queries related to labeling, including safety updates for approved labels.
• Create and maintain artwork for critical Regulatory functions: prepare labeling mock-ups for Health Authority submissions, manage expedited artwork approval process for US and ex-US market product.

• Lead the development of Standard Operating Procedures (SOPs) and process improvements for labeling generation and maintenance as neede