RhyGaze

Compliance

• Establish core Regulatory Operations processes
• Lead project planning for forthcoming major submissions
• Manage publishing vendors and internal operational platforms
• Implement Veeva RIM Basics and establish foundational RegOps processes
• Lead submission preparation, document management, metadata standards, and eCTD readiness
• Partner with Regulatory Affairs, Clinical, CMC, QA, and external vendors
• Coordinate planning and execution of IND/IMPD and CTA/CTN submissions across regions
• 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 eCTD build, validation, and gateway submission with publishing vendors
• Ensure submission components meet ICH/eCTD requirements and local agency specifications
• Implement and manage Veeva Basics RIM
• Develop document readiness checklists, RIM data entry processes, and submission archive structure
• Establish submission tracking dashboards and operational KPIs
• Implement inspection-ready document control and audit trails
• Serve as operational interface among 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 on submission status, timelines, risks, and mitigation strategies
• Ensure 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 for regulatory documentation and archives
• Safeguard RIM data integrity and controlled document lineage; maintain audit trails and submission master files

Director, Regulatory Operations