Regulatory Manager / Senior Regulatory Manager

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

Requirements

• Provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, and submissions to Regulatory Authorities
• Compile, coordinate, and review applications to Regulatory Authorities
• Develop and/or review documents intended for submission to Regulatory Authorities and/or Ethics Committees
• Serve as representative of Global Regulatory Affairs at project team meetings
• Oversee and coordinate Regulatory Affairs Specialists
• Maintain project plans, project trackers, and regulatory intelligence tools
• Assist in development of Regulatory Affairs Specialists and other operational area staff
• Provide input into regulatory strategy and timeline development for new study opportunities
• Establish company standards to ensure the highest quality of submitted information
• Participate in maintaining and executing on corporate quality initiatives

Benefits

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