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Salary: USD 230,000 - 250,000 / annual
Mirum Pharmaceuticals, a biopharmaceutical company focused on rare disease treatments, seeks a Director of Regulatory Project Management to provide strategic leadership and oversight of the Regulatory Medical Writing (RMW) Department's planning and execution of regulatory submissions.
In this role, you will partner across the RMW Department (Strategic Regulatory, CMC Regulatory, Labeling, Ad-Promo, Regulatory Information Management, and Medical Writing) and cross-functional project teams to ensure regulatory timelines and strategies are developed and executed successfully, enabling filings with global health authorities. You will co-lead Global Regulatory Project Team meetings in partnership with the Global Regulatory Lead and co-lead product/submission-specific multi-disciplinary Filing Teams.
Key responsibilities include developing and actively managing project timelines and integrated submission project plans; working with each function to understand deliverables and interdependencies to create and maintain overall project plan timelines across all modules; identifying and communicating regulatory and project risks with potential solutions; preparing meeting agendas, minutes, and documenting decisions, action items, and risk mitigation plans; preparing and distributing reports and trackers to communicate project status; proactively driving project/submission teams and establishing appropriate urgency with focus on deliverables; conducting lessons learned sessions; standardizing processes and dashboards to manage cross-portfolio RMW submission workload; tracking major submission and health authority activity to aid in regulatory resource planning; organizing key RMW Department on-site activities; and supporting the Head of Regulatory Project Management & Information Systems as required.
You will serve as a senior advisor to leadership, guiding decision-making, resource planning, and continuous improvement of RMW processes.
REQUIREMENTS:
- Bachelor's degree in biological or life sciences, related scientific discipline, pharmacy, or medicine (or international equivalent); advanced degree desirable
- 10+ years in the pharmaceutical industry with deep understanding of drug development
- Prior project management experience with NDA/MAA/Lifecycle submissions and review required
- Expert in project management with advanced expertise using related software and tools (e.g., MS Project, SharePoint, Veeva, etc.)
- Demonstrated experience leading decision-making within cross-functional teams
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently, influence senior stakeholders, set strategic project direction, and manage ambiguity
- Proactive, collaborative, and solution-oriented with strong organizational discipline
- Strong interpersonal skills and ability to lead, mentor, and develop regulatory project managers and other junior staff as needed
