Regulatory Manager

The Regulatory Manager provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.

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
• Maintain 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
• 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

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation