Regulatory Manager / Senior Regulatory Manager

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join their team. The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities and/or Ethics Committees.

Requirements

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees
• Serve as representative of Global Regulatory Affairs at project team meetings
• Works within a project team and leads project for the region or globally
• Maintains project plans, project trackers and regulatory intelligence tools
• Assists in development of Regulatory Affairs Specialists and other operational area staff
• Provides input into regulatory strategy and timeline development for new study opportunities

Benefits

• Comprehensive benefits package
• Opportunity to work with a growing organization serving clients researching ground breaking cancer therapies
• Chance to impact positive change for the company