Associate Director, Project Manager - Regulatory Affairs

Role: Associate Director, Regulatory Project Manager at Travere Therapeutics, leading global regulatory affairs activities for rare disease therapies. Objectives include ensuring compliance with health authority requirements, facilitating regulatory submissions, and supporting cross-functional collaboration throughout the product lifecycle. Responsibilities encompass developing and managing regulatory project timelines, overseeing submission planning for INDs, NDAs, and post-marketing activities, coordinating with clinical, CMC, and quality teams, preparing for regulatory interactions, and driving process improvements. Qualifications: Bachelor’s in Life Sciences or related field; 8+ years of project management experience in biotech/pharma, with regulatory-specific expertise preferred; PMP certification is highly desirable. High-Value: Focus on rare disease therapies, global regulatory submissions, and cross-functional stakeholder management; role involves supporting regulatory strategy and operational readiness in a fast-paced environment. WorkSetup: Hybrid/remote in San Diego, with less than 10% travel domestically and internationally.