Senior Director, Regulatory Affairs CMC
Mirum Pharmaceuticals(5 days ago)
About this role
Mirum Pharmaceuticals seeks a Senior Director, Regulatory Affairs CMC to lead and strategize all CMC-related regulatory submissions and interactions, ensuring compliance with global standards. This role involves overseeing the development of regulatory strategies for drug development and commercialization, and managing relationships with health authorities and internal teams.
Required Skills
- Regulatory Affairs
- CMC
- FDA
- EMA
- Biologics
- Drug Development
- Regulatory Strategy
- Global Submissions
- Leadership
- Communications
About Mirum Pharmaceuticals
mirumpharma.comMirum Pharmaceuticals is a biopharmaceutical company focused on developing transformative medicines for rare liver diseases. It develops and commercializes therapies targeting cholestatic and pediatric liver disorders, notably maralixibat (Livmarli), which is approved to treat cholestatic pruritus in patients with Alagille syndrome, and is advancing programs for other inherited cholestatic conditions such as PFIC. Mirum emphasizes patient-focused clinical development and regulatory engagement to bring treatments that reduce symptoms, improve liver function, and enhance quality of life for affected children and families.
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