Director, Regulatory Affairs Strategy

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
• Exp

Benefits

Additional Information

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.

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