Regulatory Manager / Senior Regulatory Manager

Key details

• Provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures
• Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develop and/or review documents intended for submission to Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
• Work within a project team and, where necessary, lead projects for the region or globally
• Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
• Maintain project plans, project trackers and regulatory intelligence tools and keep Regulatory Leadership updated
• Assist in development of Regulatory Affairs Specialists and other operational area staff
• Provide input into regulatory strategy and timeline development for new study opportunities and assist in establishing company standards
• Participate in maintaining and executing corporate quality initiatives across business units within clinical solutions
• Keep abreast of and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
• Provide ICH GCP guidance, advice and training to internal and external clients
• Serve as representative of Global Regulatory Affairs at business development meetings
• Company mission
• To help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients by integrating clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences