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Director, Regulatory Project Management at Mirum Pharmaceuticals - ApplyBlast

Director, Regulatory Project Management

Mirum Pharmaceuticals

13 days ago

4.0 on Glassdoor

Foster City, California, United States

Hybrid

Full Time

Director

0 applicants

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About this role

The Director, Regulatory Project Management provides strategic leadership and oversight for the planning and execution of Regulatory Medical Writing Department deliverables, including high-quality regulatory submissions and lifecycle filings. This role involves collaborating with cross-functional teams to identify submission risks, define regulatory deliverables, and build timelines to support regulatory filings through licensure. The position also serves as a senior advisor to leadership, guiding decision-making and continuous improvement of processes.

Responsibilities

Lead regulatory project management for NDA and lifecycle submissions
Develop and manage integrated submission project timelines and dashboards
Co-lead global regulatory project teams and cross-functional filing teams

Skills

Qualifications

Bachelor's degree in biological or life sciences or related scientific discipline, pharmacy or medicine

About Mirum Pharmaceuticals

mirumpharma.com

Headquarters

Foster City, California, United States

Company Size

201-500 employees

Founded

2018

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Mirum Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing patient-inspired therapies for rare diseases where unmet medical need is greatest. The company has three approved medicines and a broad pipeline of investigational therapies spanning multiple rare disease areas, including cholestatic liver diseases and conditions such as Fibrodysplasia Ossificans Progressiva. Mirum combines deep rare disease expertise with regulatory strategy and patient access considerations to deliver meaningful treatments to small, high-need patient populations worldwide.