Regulatory Project Management Manager

Job Summary

A company is looking for a Manager, Regulatory Project Management to support regulatory planning and submission activities.

Key Responsibilities

• Serve as back-up to the Regulatory Planning lead and ensure continuity of regulatory planning activities
• Support development and maintenance of integrated global regulatory timelines and provide project management for major submissions
• Facilitate Global Regulatory Strategy Team meetings and prepare status updates and planning materials for stakeholders

Required Qualifications, Training, and Education

• Bachelor's degree in life sciences or related discipline
• 5+ years of experience in regulatory affairs, regulatory operations, or regulatory project management in the biotech or pharmaceutical industry
• Experience supporting a major regulatory submission (e.g., NDA, BLA, MAA)
• Working knowledge of global regulatory submission processes and lifecycle management
• Proficiency with project planning tools (e.g., Smartsheet, MS Project, or similar platforms)