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.

Position Summary: 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.

Responsibilities:

• 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 providing labeling information requests related to assigned products and overall labeling processes.
• Manages the Structured Product Label (SPL) process; collaborates with external vendors, ensures SPL is acceptable for submission, and confirms successful submission with Regulatory Operations.
• Lead and actively contribute to the continuous improvement of labeling processes, identifying opportunities for optimization to enhance efficiency.
• Additional duties assigned as needed.

Education/Experience Requirements:

• Bachelor's degree in a scientific discipline such as Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required. Equivalent combination of education and applicable job experience may be considered
• Advanced degree (MS, PhD, PharmD, or equivalent) in related discipline preferred.
• 8+ years of relevant pharmaceutical or biotech industry experience. Including 6 years of direct labeling experience or combination of 5+ years regulatory and related experience.
• Strong knowledge of US and EU product labeling requirements, regulations, and guidelines (USPI and EU SmPC experience required).

Additional Skills/Experience:

• The ideal candidate will embody Travere’s core values: Courage, Community Spirit, Patient Focus and Teamwork
• Driven, intelligent, passionate about making a difference for patients with rare diseases
• Experience in developing and revising product labeling (e.g. USPI and EU SmPC), as well as preparing product labeling for regulatory submissions in compliance with regulations with minimal supervision.
• Experience with US and regulatory requirements, guidelines, and procedures including global regulatory submissions, including INDs, IMPDs/CTAs, BLAs/NDAs, and MAAs.
• Experience as a Global Labeling Lead supporting local-label implementation and deviation management across multiple regions.
• Knowledge of scientific principles and regulatory/quality systems relevant to the drug development phases to commercial phase.
• Ability to develop target product labels (TPL).
• Knowledge of the Structured Product Label (SPL) process and submission.
• Experience in pharmaceutical packaging systems, including container label and carton.
• Excellent project management and organizational skills with the ability to manage multiple programs and competing priorities.
• Strong written and verbal communication skills with the ability to effectively influence cross-functional stakeholders and senior leadership.
• Demonstrated regulatory judgment, strategic thinking, and problem-solving capabilities.
• Ability to work independently and effectively within a matrixed, cross-functional environment.
• Ability to travel 10% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

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: $150,000.00 - $195,000.00 *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 [email protected]. 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.