Regulatory Manager / Senior Regulatory Manager

Precision for Medicine is recruiting a Regulatory Manager / Senior Regulatory Manager to join their team, providing regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities.

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 Regulatory Authorities
• Serve as representative of Global Regulatory Affairs at project team meetings
• Works within a project team, and where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists
• Maintain project plans, project trackers and regulatory intelligence tools
• Assist in development of Regulatory Affairs Specialists
• Provide input into regulatory strategy and timeline development for new study opportunities
• Participate in maintaining and executing on the corporate quality initiatives
• Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan