Director, Regulatory Affairs Strategy

Travere Therapeutics

Director of Regulatory Affairs Strategy at Travere Therapeutics focused on rare disease development and regulatory excellence. Collaborating with cross-functional teams to navigate global regulatory requirements.

Posted 6/24/2026full-timeRemote • California • 🇺🇸 United StatesLead💰 $189,000 - $246,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategyclinical developmentpivotal trial designregulatory compliancesubmission documentsINDsNDABLAMAAclinical trial regulations

Soft Skills

leadershipmentoringcollaborationcommunicationstrategic planningrisk assessmentnegotiationorganizational skillsguidanceevaluation

Certifications

Bachelor’s degreePhDPharmDMDMS