Associate Director, Regulatory Labeling Strategy

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.

The Associate Director, Labeling Strategy is responsible for developing and executing global regulatory labeling strategies throughout the product lifecycle. This role serves as the labeling lead for assigned development and commercial products, ensuring that prescribing information and patient labeling are scientifically accurate, compliant with local regulations, and aligned with the company's strategic objectives.

The Associate Director will partner closely with Regulatory Affairs, Clinical Development, Drug Safety and Pharmacovigilance, Medical Affairs, Commercial, and Legal, and Quality teams to lead the development, negotiation, implementation, and maintenance of product labeling. The individual will provide strategic guidance on labeling implications for development programs, regulatory submissions, and post-marketing activities.

• Independently leads Labeling multi-disciplinary team (Labeling Working Group - LWG) driving cross-functional collaboration to gain alignment on labeling strategy and labeling content.
• Coordinates the process to obtain labeling approval by Executive Labeling Board (ELB), as applicable to the review and approval process.
• Authors new/revised TPL, CCDS, and USPI for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations/supporting documents.
• Develops and executes a global labeling implementation plans to incorporate new scientific, safety and clinical data, as well as Health Authority responses into CCDS/USPI enabling the most current information and in compliance with labeling requirements Health Care Providers and patients.
• Independently authors and manages communications regarding CCDS and labeling updates for assigned products.
• Demonstrates strong project management skills to coordinate global labeling functions to ensure timely Health Authority submission and key role in label negotiations with Health Authorities.
• Interprets regulations and guidance documents relevant to the development and implementation of labeling documents and assures labeling content and processes conform to regulatory requirements.
• Manages process for alignment of local labeling with CCDS for assigned products, including assessment of labeling deviations in US, EU, and ROW.
• Provides strategic direction and subject-matter guidance to Local Labeling Leads for responses to health authorities' requests/labeling negotiations.
• Appropriately presents issues and seeks endorsement from Executive Labeling Board for proposed risk mitigation strategies, labeling negotiations strategies, and other important/major labeling updates for assigned products.
• Conducts precedent, analyzes relevant competitor labeling, assesses labeling guidance and trends, and develops labeling strategies and language for assigned product labels (TPL, CCDS, USPI) to ensure consistency with the overall product strategy, product claims and information in the CCDS and to ensure the most competitive labeling possible.
• Represents Global Labeling at Regulatory Satellite, Regulatory Product Strategy, business partner meetings, and other initiatives.
• Provides regulatory input for the development and revision of carton and container artwork. Collaborate with Technical Operations to implement approved labeling into packaging.
• Supports Health Authority Inspections by…