Regulatory Manager / Senior Regulatory Manager

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 where necessary, leads project for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintenance of project plans, project trackers and regulatory intelligence tools
• Assist in development of Regulatory Affairs Specialists and other operational area staff
• Provide input, as required, into regulatory strategy and timeline development for new study opportunities
• Assists in establishing company standards to ensure the highest quality of submitted information
• Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions
• Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
• Provides ICH GCP guidance, advice and training to internal and external clients
• Serve as representative of Global Regulatory Affairs at business development meetings

Benefits

• Healthcare benefits
• Retirement plan
• Stock options
• Paid time off