Director, Global Regulatory Affairs

Benefits

Additional Information

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 for assigned projects and support Global Regulatory Project Team activities, ensuring International regulatory compliance and the timely delivery of submissions, approvals, and lifecycle management procedures. The scope includes, but is not limited to, high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), clinical trial applications, rare disease designations, major supplements/variations, and lifecycle submissions for assigned programs in International markets, as applicable. JOB FUNCTIONS/RESPONSIBILITIES Regulatory Strategy and Leadership Develop and lead International regulatory strategies for assigned programs in alignment with global development and commercial objectives, under the guidance of senior Global Regulatory Affairs leadership. Serve as the Regional Regulatory Lead for assigned programs and represent International Regulatory Affairs on Program Teams and Global Regulatory Project Teams, as needed. Provide International regulatory guidance across the product lifecycle, including development strategy, country and regional requirements, submission planning, change control assessment, registration pathways, and lifecycle management. Cross-functional Planning and Execution Contribute to Global Regulatory Project Team meetings in partnership with the Global Regulatory Lead and Regulatory Project Management, ensuring clear plans, timelines, risks, assumptions, decision points, and cross-functional alignment. Lead and/or oversee the preparation of regulatory documentation for Health Authority interactions, including meeting requests, briefing packages, clinical trial applications, marketing authorization applications, variations and amendments, and responses to Health Authority questions. Critically review submission documents to ensure scientific quality, regulatory compliance, consistency, and alignment with agreed International and global regulatory strategy. Stakeholder Collaboration and External Engagement Partner with Regulatory Project Management, Regulatory CMC, Regulatory Labelling, Medical Writing, Clinical Operations, Clinical Development, Nonclinical, Pharmacovigilance, Quality, Biometrics, Commercial, and other cross-functional stakeholders to deliver timely, high-quality International regulatory outputs. Build and maintain effective relationships with international partners, distributors, local regulatory representatives, and external vendors to support submissions, approvals, and post-approval activities across International markets. Participate in Health Authority meetings and support preparation, negotiation strategy, meeting conduct, follow-up actions, and communication of outcomes to internal stakeholders. Regulatory Operations and Compliance Contribute to and review responses to Health Authority questions to ensure they are appropriate, consistent, complete, and strategically aligned across International markets. Maintain current knowledge of EMA, EU, UK, Swiss, and other International regulatory requirements, guidance, and industry practices, while remaining aware of US FDA and Health Canada requirements that may affect global development strategy. Support major regulatory procedures and deliverables, including MAA-related activities, clinical trial applications, Pediatric Investigation Plans, Orphan Drug Designation activities, post-marketing commitments, variations and amendments, and lifecycle management activities, as applicable. Work with technical, medical writing, and cross-functional colleagues to support International product prioritization and special designation requests, where applicable, and ensure alignment with broader development strategy. Communication and Team Support Clearly articulate regulatory challenges, risks, options, a

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at mirumpharmaceuticals? Share your experience