Revolution Medicines is seeking an Associate Director, Global Regulatory Affairs Project Management to join their team. The ideal candidate will have an in-depth understanding of oncology drug development and demonstrated hands-on regulatory project management experience supporting early- and late-stage registrational programs.
Requirements
- Project manages regulatory submissions from initiation through submission
- Develops, maintains, and tracks comprehensive submission timelines for INDs / CTAs, NDAs / MAAs, amendments, agency interactions, and other key global regulatory activities
- Partners with Global and Regional Regulatory Science Leads to advance global regulatory strategies for assigned molecules across indications
- Facilitates Global Regulatory Teams and meetings to ensure coordinated development and execution of high-quality, timely global regulatory deliverables at the study level
- Drives the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams
- Coordinates with global partners to maintain consistent regulatory program plans, ensuring alignment, compliance, and continuity across regions
- Builds and maintains submission dashboards; communicates status, risks, and mitigation strategies to senior management and key stakeholders
- Supports the development, implementation, and continuous improvement of global regulatory project management processes, templates, tools, dashboards, analytics, and best practices
Benefits
- Competitive cash compensation
- Robust equity awards
- Strong benefits
- Significant learning and development opportunities