Mirum Pharmaceuticals is seeking a Director, Global Regulatory Affairs to provide strategic leadership and execution for clinical development and lifecycle management programs associated with rare diseases. The role will involve representing the regulatory function, providing guidance across internal stakeholders, and ensuring International regulatory compliance and timely delivery of submissions, approvals, and lifecycle management procedures.
Requirements
- Bachelorâs degree in biological or life sciences, pharmacy, medicine, or a related scientific discipline
- 10+ years of experience in the pharmaceutical industry, including 8â10 years in Global Regulatory Affairs
- Deep understanding of drug development and substantial experience with international regulatory procedures and major Health Authorities
- Strong understanding of EMA, EU, UK, Swiss, and broader international regulatory guidance, regulations, drug development processes, and industry practices
- Excellent written and verbal communication skills, with strong personal integrity and sound judgment
- Strategic problem-solving, negotiation, and decision-making skills
Benefits
- Generous Paid Time Off
- 401k Matching
- Relocation Assistance