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 Associate Director, Regulatory Project Manager (RPM) at Travere Therapeutics is responsible for leading and coordinating global regulatory affairs activities to ensure compliance with health authority requirements. This role supports regulatory submissions for investigational and commercial rare disease therapies, facilitates cross-functional collaboration and manages timelines to achieve company objectives in a fast-paced, patient-focused environment. This position works with the Regulatory Affairs Strategy leaders to create regulatory project timelines and dashboards, schedule cross-functional meetings, and track regulatory commitments.

Responsibilities:

Lead regulatory project management activities for one or more global development programs ensuring regulatory plans, timelines, deliverables, and submission activities are aligned with program strategy and corporate priorities. Partner closely with Regulatory Leads to drive Global Regulatory Team meeting operations, including agenda planning, decision tracking, meeting documentation, and follow-up on key actions and commitments. Develop, maintain, and manage integrated regulatory project timelines that reflect global health authority milestones, cross-functional dependencies, submission deliverables, and key decision points across the product lifecycle. Oversee planning and tracking of major regulatory submissions and maintenance activities, including INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, health authority responses, and other regulatory deliverables. Collaborate with Regulatory Operations, Regulatory Affairs, Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing, Quality, Commercial and external partners/vendors to ensure timely and high-quality execution of regulatory deliverables. Support submission planning and operational readiness by coordinating content planning, submission timelines, document ownership, review cycles, and Vault RIM-related activities in partnership with Regulatory Operations and Regulatory Leads. Create and maintain regulatory dashboards, milestone trackers, and status reports to provide visibility to Regulatory Affairs leadership, program teams, and senior management on progress, risks, issues, and upcoming deliverables. Identify, communicate, and help mitigate regulatory project risks, timeline constraints, resource gaps, and cross-functional dependencies that may impact submission readiness, health authority commitments, or program execution. Support preparation for health authority interactions, advisory committee activities, inspection readiness, audits, and regulatory responses by coordinating timelines, materials, contributors, and action follow-up. Drive continuous improvement of regulatory project management processes, tools, templates, meeting operations, dashboards, and ways of working to improve consistency, efficiency, and scalability across programs. Manage regulatory project documentation and ensure key decisions, action items, timelines, submission plans, and deliverables are appropriately captured, maintained, and accessible in designated systems or repositories. Provide leadership, mentoring, and guidance to regulatory project management team members and cross-functional partners; may manage direct reports or support resource planning across multiple programs as the function evolves. Additional duties assigned as needed.

Education/Experience Requirements:

Bachelor's degree in related Life Sciences or related discipline required. MS, Pharm D, PhD preferred. Equivalent combination of education and applicable job experience may be considered. 8+ years of Project Management experience in Biotech or Pharmaceutical industry. Regulatory specific project management experience preferred. PMP certification is strongly preferred. Expertise with timeline development and management software required (e.g., Smartsheets, MS Project).

Additional Skills/Experience:

The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork. Driven, intelligent, passionate about making a difference for patients with rare diseases. Strong understanding of global regulatory affairs, submission requirements, and compliance processes for rare disease therapies. Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. Excellent project management skills, including scheduling, risk management, and stakeholder coordination in a fast-paced biotech setting. Strong communication, organizational, and... For full info follow application link. 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