Director, Regulatory Affairs 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 Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical development, registration, and commercialization of investigational products. This individual serves as the regulatory lead for assigned programs and provides strategic guidance to cross-functional teams, ensuring alignment with global regulatory requirements and corporate objectives. The Director partners closely with Clinical Development, Clinical Operations, Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial, and Executive Leadership to drive regulatory excellence throughout late-stage development. The role requires extensive experience interacting with global health authorities, including the FDA, EMA, and other regulatory agencies. Responsibilities : Regulatory Strategy & Leadership Develop and lead global regulatory strategies for Phase 2 and Phase 3 clinical development programs. Provide regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways. Evaluate regulatory risks and opportunities and develop mitigation strategies to support program objectives. Lead regulatory planning for major milestones, including End-of-Phase 2 meetings, Scientific Advice procedures, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications. Serve as the regulatory representative on cross-functional program teams and governance committees. Health Authority Interactions Lead preparation, coordination, and execution of global regulatory agency meetings and interactions. Develop briefing documents, regulatory questions, meeting strategies, and response packages. Represent the company during regulatory agency meetings and negotiations. Ensure alignment of regulatory strategy across regions while addressing local market requirements. Regulatory Submissions Oversee the preparation and submission of global regulatory documents, including: INDs and IND amendments Clinical Trial Applications (CTAs) Annual reports and Development Safety Update Reports (DSURs) Pediatric plans and orphan drug submissions NDA, BLA, MAA, and other marketing applications Review and approve key submission documents to ensure regulatory compliance, scientific integrity, and strategic consistency. Cross-Functional Collaboration Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory considerations into development plans. Provide regulatory leadership for label development and commercialization planning. Support due diligence activities, business development initiatives, and portfolio evaluations as needed. Mentor and develop regulatory staff and contribute to building organizational regulatory capabilities. Regulatory Intelligence & Compliance Monitor evolving global regulatory requirements, guidance documents, and industry trends. Assess potential impact of regulatory changes on development programs and advise leadership accordingly. Ensure compliance with applicable regulatory regulations, guidelines, and company procedures. Education/Experience Requirements: Bachelor’s degree in a scientific or related field required. Equitable combination of skills and relevant experience are also considered Advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Affairs, or related discipline preferred (PhD, PharmD, MD, or MS) 10+ years of progressive regulatory affairs experience within the pharmaceutical, biotechnology, or life sciences industry Significant experience leading regulatory strategy for Phase 2 and Phase 3 development programs Demonstrated success managing interactions with FDA and other major global health authorities Experience supporting or leading NDA, BLA, MAA, or equivalent marketing application submissions Strong understanding of global drug development, regulatory frameworks, and clinical trial regulations Experience in one or more therapeutic areas such as oncology, rare disease, immunology, neuroscience, or metabolic disease preferred Additional Skills/Experience/Requirements: 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 Exceptional communication, negotiation, and influencing skills Ability to effectively manage complex regulatory issues in a fast-paced environment Strong leadership and cross-functional collaboration capabilities Strong strategic thinking with strong business and scientific acumen, problem-solving, and decision-making capabilities Strong interpersonal and proactive approach. Able to work both independently and in a team environment Detail-oriented, with good organizational, prioritization, and time management proficiencies Proven ability to manage multiple priorities in a fast-paced environment Ability to work effectively across global time zones when necessary Some travel (10-15%) may be required, with the potential for travel occurring over weekends 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: $189,000.00 - $246,000.00 *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.