Director, Regulatory Submissions & PM (Hybrid)

Regulatory Jobs; 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 for Regulatory Medical Writing. You will guide timelines, risks, and cross-functional collaboration to support high-quality regulatory submissions (NDAs, MAAs, INDs) and lifecycle filings.

The role requires senior-level leadership, strong communication, and the ability to influence across functions and with senior stakeholders. Hybrid work options are available.

Qualifications

• Bachelor’s degree in biological or life sciences or related discipline. 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

• Partner across the RMW department and cross-functional teams to ensure timelines and strategies are executed.
• Co-lead Global Regulatory Project Team (GRPT) meetings with GRL.
• Develop and manage integrated submission project plans across Modules 1-5.
• Identify regulatory and project risks and propose solutions to leadership.
• Prepare agendas, minutes, decisions and risk mitigation plans; centralize team information.
• Organize reports and trackers to communicate status and updates.

Skills

Project leadership

Stakeholder influence

Strong communication

Independent work

Mentoring

Education

Bachelor in life sciences

Advanced degree desirable

Tools

MS Project

SharePoint

Veeva

Job description

Mirum Pharmaceuticals is seeking a Director of Regulatory Project Management to lead planning and execution for Regulatory Medical Writing. You will guide timelines, risks, and cross-functional collaboration to support high-quality regulatory submissions (NDAs, MAAs, INDs) and lifecycle filings.

The role requires senior-level leadership, strong communication, and the ability to influence across functions and with senior stakeholders. Hybrid work options are available.