Senior Director, Global Labeling Regulatory Affairs

Department:

Location:

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 needed to ensure high performing labeling operations and effective review processes.
• Staff and develop team members within global labeling regulatory.

Education/Experience Requirements: 

• Bachelor’s Degree in Life Science or other related discipline.  Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered. 
• Minimum of 12 years’ regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 8-10 years’ experience in a regulatory leadership role. Understands Regulatory, Quality and Supply Chain aspects of labeling and impact of non-compliance.
• Strong expertise and knowledge of applicable regulations and standards for FDA and EMA product investigational and commercial labeling and packaging requirements, regulations, and guidelines (USPI and EU SmPC experience required).
• Knowledge of Clinical Supply Packaging and/or Labeling and/or Distribution with external vendors (e.g. technical, process, plan or system).

• Strong collaboration, presentation, communication, interpersonal, and leadership skills.

Additional Skills/Experience: 

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork.

• Strong professional experience in a similar role within the pharmaceutical industry, preferably small and large molecule pharmaceuticals, as well as combination products. 
• Excellent collaboration skills with strong attention to detail and the ability to adapt to change, multi-task, prioritize, manage complexities, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment demonstrating flexibility to implement new strategies and tactics to accommodate these changes.
• Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Excellent team management skills, ability to lead, train and mentor team members at all levels.
• Work independently with minimal supervision. Exercises judgment within defined practices and policies.
• Ability to travel 10-20% domestic and internationally. 
   

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Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse, equitable, people-centric, and pay-for-performance organization.    

Benefits: Our benefits include premium health, financial, work-life and well-being offerings for eligible employees and dependents, wellness and employee support programs, life insurance, disability, retirement plans with employer match and generous paid time off.

Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.

Target Base Pay Range:

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidate’s experience, education, skills, and location. 

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

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

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to accommodations@travere.com. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.