Director, Regulatory Affairs Strategy

Travere • San Diego, CA

9h • Remote

About The Position

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 toப் 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.

Requirements

• Bachelor’s degree in a scientific or related field required.
• Equitable combination of skills and relevant experience are also considered
• 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
• 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

Nice To Haves

• Advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Affairs, or related discipline preferred (PhD, PharmD, MD, or MS)
• Experience in one or more therapeutic areas such as oncology, rare disease, immunology, neuroscience, or metabolic disease preferred

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Benefits

• 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
• generous paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Director