Director, Regulatory Project Management (Hybrid)

Mirum Pharmaceuticals, Inc.; Foster City (CA); Hybrid; USD 230,000 - 250,000; Full time

Job summary

Mirum Pharmaceuticals is seeking a Director of Regulatory Project Management to lead planning and execution of Regulatory Medical Writing deliverables, including high-quality submissions for NDAs, MAAs, INDs, rare disease designations, and lifecycle filings across assigned programs.

The role partners with the GRL, regulatory team and cross-functional partners to identify risks, build timelines, and ensure timely regulatory filings through licensure and beyond, while mentoring staff and driving

Qualifications

• Bachelor’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent). An advanced degree is desirable.
• 10+ years in the pharmaceutical industry with a deep understanding of drug development.
• Prior project management experience with NDA/MAA/Lifecycle submissions and review is required.

Responsibilities

• Lead regulatory project management across cross-functional teams to ensure timely filings.
• Co-lead Global Regulatory Project Team (GRPT) and multi-disciplinary filing teams.
• Develop and manage integrated submission plans and timelines across Modules 1-5.
• Identify regulatory and project risks, proposing solutions to leadership.
• Organize meetings, document decisions, and track project status.
• Mentor and develop junior regulatory project managers.

Skills

Project management

Cross-functional leadership

Communication

Decision making

Mentoring

Ambiguity management

Education

Bachelor's degree in biological or life sciences or related field

Advanced degree desirable

10+ years in pharma

Tools

MS Project

Sharepoint

Veeva

Job description

Mirum Pharmaceuticals is seeking a Director of Regulatory Project Management to lead planning and execution of Regulatory Medical Writing deliverables, including high-quality submissions for NDAs, MAAs, INDs, rare disease designations, and lifecycle filings across assigned programs.

The role partners with the GRL, regulatory team and cross-functional partners to identify risks, build timelines, and ensure timely regulatory filings through licensure and beyond, while mentoring staff and driving