Remote Regulatory Manager / Senior Regulatory Manager

Summary

Join Precision for Medicine (CRO) as a Regulatory Manager to provide regulatory strategy and development guidance for clinical trials, maintain knowledge of regulations, and prepare well-organized regulatory submissions. The role involves coordinating and preparing regulatory documents, providing analysis to project teams, and supporting the corporate Regulatory function.

Requirements

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
• 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
• Computer literacy (MS Office/ Office 365)
• Fluent in English

Responsibilities

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications
• Develops and/or reviews documents intended for submission to the 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
• 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 as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
• Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
• 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

Preferred Qualifications

• Graduate, postgraduate
• Possesses basic understanding of financial management