Regulatory Project Lead - Global Submissions (Remote)

Travere Therapeutics; Providence (RI); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics is seeking an Associate Director of Regulatory Project Management to lead global regulatory activities, coordinate cross‑functional teams, and drive submissions for rare disease therapies. The role focuses on timelines, dashboards, and maintaining alignment with program strategy.

You will partner with Regulatory Leads, Regulatory Operations, Clinical Development, and other functions to ensure timely deliverables, risk mitigation, and continuous process improvement in a

Qualifications

• Bachelor's degree in Life Sciences or related field required; advanced degrees preferred.
• 8+ years of project management experience in biotech/pharma, regulatory-focused preferred.
• PMP certification strongly preferred; experience with timeline software required (Smartsheets/MS Project).

Responsibilities

• Lead regulatory project management across global development programs with aligned plans and submissions.
• Coordinate Global Regulatory Team meetings, action tracking, and documentation.
• Develop and maintain integrated regulatory timelines and dashboards.
• Oversee regulatory submissions (INDs, NDAs, BLAs) and post‑marketing commitments.
• Collaborate with Regulatory Ops, Clinical Development, QA, and external partners to ensure timely delivery.
• Support inspection readiness and advisory committee activities; manage risk and cross‑functional dependencies.
• Mentor Regulatory PM staff and contribute to process improvements across programs.

Skills

Regulatory project management

Global regulatory affairs

PMP certification

Education

Bachelor's degree in Life Sciences or related discipline

MS, PharmD, PhD preferred

Tools

Smartsheets

MS Project

Job description

Travere Therapeutics is seeking an Associate Director of Regulatory Project Management to lead global regulatory activities, coordinate cross‑functional teams, and drive submissions for rare disease therapies. The role focuses on timelines, dashboards, and maintaining alignment with program strategy.

You will partner with Regulatory Leads, Regulatory Operations, Clinical Development, and other functions to ensure timely deliverables, risk mitigation, and continuous process improvement in a