Vice President, Regulatory Strategy Diligence at Travere Therapeutics in San Diego, CA

Job description

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: Travere is seeking a Vice President, Regulatory Strategy Diligence to lead the Regulatory Due Diligence team including Regulatory Strategy assessments of clinical/commercial-stage assets associated with external business development opportunities. This individual will evaluate potential licensing, acquisition, partnership, and external innovation opportunities, identifying material technical risks and practical mitigation strategies across asset development, including endpoint assessment, development path, key milestones, phase appropriate readiness, manufacturing, supply chain, and commercial readiness. The role will closely collaborate with Business Development, Non-clinical, Clinical, Commercial, Legal, Regulatory, Technical Operations and Quality leaders to support transaction decisions and post-deal integration planning. The successful candidate will ensure Regulatory considerations for Nonclinical, Clinical and Reg CMC are fully integrated into the overall business development strategy and help Travere distinguish material risks from manageable issues to make informed investment and partnership decisions. The ideal candidate brings deep Regulatory development expertise across small molecules, biologics (including gene therapy), ATMPs and Companion Diagnostics, shows sound business judgment, is experience in confidential transaction environments, and possesses the ability to effectively translate complex technical findings into clear executive-level recommendations. Key Responsibilities: Lead the Regulatory due diligence for licensing, acquisition, partnership, and external innovation opportunities by assessing readiness risks for clinical/commercial-stage assets. Evaluate drug/device regulatory development including all levels of product development, pediatrics, Regulatory strategies, Agency feedback, risks and mitigations along with Timelines and development strategies. Own the integrated regulatory risk assessment and recommendation for each opportunity, Identify and champion activities relating to risk and its mitigation distinguishing transaction critical issues; communicate key assumptions, dependencies, potential timeline effects, and proposed mitigation. Evaluate CMC drug substance/product manufacturing, product development, control strategies, analytical, validation, stability, technology transfer, and lifecycle management plans. Review regulatory aspects of CRO/CMO capabilities, capacity, compliance history, performance, network redundancy, supply continuity, and readiness to support clinical and/or commercial supply. Partner with Business Development, Corporate Strategy, Non-clinical, Clinical, Pharmacovigilance, Quality, Regulatory, Finance, Legal, Program Management, and Technical Operations stakeholders. Prepare timely, concise diligence reports, risk registers, executive p