Manager of Regulatory Affairs

Job Summary

Managing regulatory submissions and project activities, the full-time Manager of Regulatory Affairs will lead planning and execution of submissions, coordinate cross-functional communication, and maintain project documentation in a remote environment.

Key responsibilities

• Lead the planning, coordination, and execution of regulatory submissions and activities, including INDs, NDAs, and CTAs
• Serve as the primary regulatory project management contact, communicating project status and risks to stakeholders
• Prepare and maintain regulatory submission trackers and project dashboards, documenting key milestones and updates

Required qualifications

• Bachelor's degree or higher in a scientific or related discipline
• Minimum of 5 years of experience in regulatory affairs, project management, or life sciences
• Hands-on experience with major global regulatory submissions, preferably in oncology
• Strong knowledge of global regulations and regulatory standards
• Demonstrable proficiency in project timeline and Gantt chart software, as well as MS Office applications