Global Regulatory Strategy Lead – Rare Diseases

Mirum Pharmaceuticals, Inc.; Foster City (CA); Hybrid; USD 280,000 - 310,000; Full time

Job summary

Mirum Pharmaceuticals, Inc. in Foster City, CA, is seeking a Senior Director, Global Regulatory Affairs to provide regulatory strategic leadership across rare-disease programs.

This role leads global regulatory strategy, interfaces with Health Authorities, and guides cross-functional teams to ensure timely submissions and approvals. The successful candidate will have 15+ years in pharma, 12+ in GR affairs, and proven experience with NDA/MAA submissions, regulatory labeling, and lifecycle

Qualifications

• Bachelor’s or Master’s in biological or life sciences (or related field).
• Minimum 15 years in pharma with 12+ in Global Regulatory Affairs.
• Experience with US FDA, EU/EMA and Health Canada guidance and regulations.
• Experience with major submissions (NDA/MAA) and pediatric/orphan designations preferred.
• Willingness to travel 10–15% and work on-site 2 days/week.

Responsibilities

• Develops and oversees global regulatory strategy for projects in assigned TA.
• Leads Global Regulatory Project Team meetings when acting as Global Regulatory Lead.
• Oversees preparation of regulatory documentation for Health Authority interactions.
• Reviews submissions to ensure regulatory compliance and quality.
• Contributes to responses to Health Authority questions and aligns with strategy.
• Provides regulatory guidance through product lifecycle across programs.
• Oversees content and format for submissions and variations internationally.
• Participates in Health Authority meetings.
• Articulates regulatory risks and recommends paths forward to teams and senior management.
• Maintains knowledge of regulatory requirements and communicates changes.
• Mentors junior professionals and manages direct reports.

Skills

Global Regulatory Strategy

Health Authority Engagement

Regulatory Submissions

Regulatory Project Leadership

Cross-functional Collaboration

Education

Bachelor’s or Master’s degree in biological or life sciences

Advanced degree desirable

Job description

Mirum Pharmaceuticals, Inc. in Foster City, CA, is seeking a Senior Director, Global Regulatory Affairs to provide regulatory strategic leadership across rare-disease programs.

This role leads global regulatory strategy, interfaces with Health Authorities, and guides cross-functional teams to ensure timely submissions and approvals. The successful candidate will have 15+ years in pharma, 12+ in GR affairs, and proven experience with NDA/MAA submissions, regulatory labeling, and lifecycle