Regulatory Project Manager

Job Summary

A company is looking for a Regulatory Associate Project Manager to join their Consulting Services team.

Key Responsibilities

• Serve as the project manager for assigned client projects, leading the planning and execution of regulatory activities
• Manage the preparation, review, and assembly of regulatory submissions to global health agencies
• Collaborate with cross-functional teams to track project progress and ensure timely delivery within budget

Required Qualifications

• Bachelor's degree in a science or health-related field
• 2+ years of experience in the pharmaceutical, device/diagnostics, or biotech industry
• 1-2 years of Regulatory or Project Management experience within a CRO, pharma, device/diagnostics, or biotech company
• Foundational knowledge of the drug development process and experience with IND/CTA and/or marketing application submissions
• Strong understanding of Project Management software, with preference for SmartSheet and SharePoint experience