Director, Global Regulatory Affairs

Job description

MISSION: Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. POSITION SUMMARY: The Director, Global Regulatory Affairs – International Region will play a significant role in providing International (ex‑North America) regulatory strategic leadership and execution for assigned clinical development and lifecycle management programs associated with rare diseases. This role will represent the regulatory function and provide guidance across internal R&D stakeholders and cross‑functional Program Teams, including Clinical Development, Clinical Operations, Biometrics, Nonclinical, Pharmacovigilance, Quality, Regulatory CMC, Regulatory Labelling, Regulatory Project Management, Medical Writing, corporate partners, and distributors, as applicable, across multiple countries. The Director will act as the Regional Regulatory Lead f...