RhyGaze

Compliance

• Establish core Regulatory Operations processes and scalable systems from scratch
• Lead project planning for forthcoming major regulatory submissions
• Coordinate planning and execution of IND/IMPD and CTA/CTN submissions across regions
• Develop content plans and document templates as needed
• Build and manage integrated project plans covering critical paths, dependencies, and risks
• Drive on-time, right-first-time delivery
• Manage document readiness workflows including authoring, QC, formatting, and approval routes
• Coordinate with publishing vendors for eCTD build, validation, and gateway submission
• Ensure submission components meet ICH/eCTD requirements and local agency specifications
• Implement and manage RhyGaze’s Veeva Basics RIM
• Develop document readiness checklists, RIM data entry processes, and submission archive structures
• Establish submission tracking dashboards and operational KPIs
• Implement inspection-ready document control and audit-trail processes
• Serve as the operational interface between Regulatory Affairs, Medical Writing, CMC, Nonclinical, Clinical, QA, and external partners
• Manage publishing vendor timelines, quality oversight, and validation review
• Take on publishing responsibilities within Veeva Basics RIM when needed
• Report submission status, timelines, risks, and mitigation strategies
• Ensure regulatory documentation and submissions comply with ICH, FDA, EMA, MHRA, Health Canada, and regional requirements
• Develop quality gates and review processes
• Support GCP/GMP inspection readiness related to regulatory documentation and archives
• Safeguard RIM data integrity, controlled document lineage, audit trails, and submission master files

Director, Regulatory Operations