Senior Regulatory Project Manager - Remote

Travere Therapeutics; United States; Hybrid; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health

Retirement plans with employer match

Generous paid time off

Life insurance

Disability insurance

Work-life balance programs

Job summary

Travere Therapeutics, based in San Diego with optional remote work, seeks an Associate Director of Regulatory Project Management to lead global regulatory submissions and timelines. You will coordinate cross-functional teams, maintain integrated project plans, and drive risk management in a fast-paced rare-disease setting.

The ideal candidate has 8+ years in biotech/pharma PM, PMP preferred, and strong experience with INDs/NDAs/BLAs.

Qualifications

• Bachelor's degree in Life Sciences or related discipline; MS/PharmD/PhD preferred.
• 8+ years of project management experience in biotech or pharmaceutical industry; regulatory PM preferred.
• PMP certification strongly preferred.
• Expertise with timeline development and management software.

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 accessed 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.

Skills

Regulatory project management

Global submissions

Regulatory dashboards

Timeline development

Smartsheets

MS Project

PMP certification

Education

Bachelor's degree in Life Sciences

MS/PharmD/PhD preferred

Tools

Smartsheets

MS Project

Job description

Travere Therapeutics, based in San Diego with optional remote work, seeks an Associate Director of Regulatory Project Management to lead global regulatory submissions and timelines. You will coordinate cross-functional teams, maintain integrated project plans, and drive risk management in a fast-paced rare-disease setting.

The ideal candidate has 8+ years in biotech/pharma PM, PMP preferred, and strong experience with INDs/NDAs/BLAs.