Compliance

• Lead and execute regulatory strategy, submissions, and approvals across participating countries throughout the study lifecycle
• Develop and manage regulatory and start-up project plans
• Coordinate and submit Clinical Trial Applications to applicable regulatory bodies, import/export licenses, and other regulatory applications
• Submit substantial and non-substantial modifications and required trial notifications for maintenance studies
• Lead and execute EU interventional clinical study activities in CTIS, including overall submission strategy and Part I preparation and completion
• Act as primary regulatory and submissions lead for sponsors and project teams
• Align timelines, deliverables, submission strategies, document readiness, and regulatory requirements
• Identify, communicate, and manage risks, issues, and contingency plans; escalate critical concerns and recommend resolutions
• Lead regulatory and submission discussions during kick-off meetings and internal/external study calls
• Prepare, review, and secure sponsor approval of core submission documents and country-specific submission packages
• Review clinical and regulatory documents for compliance, completeness, quality, and country-specific acceptability
• Define Greenlight Package templates and coordinate country and site greenlight packages with Study Start-Up Associates
• Support country and site activation strategies with other functional areas
• Ensure high-quality, compliant regulatory and start-up execution
• Monitor study start-up budgets and contractual obligations and identify out-of-scope activities
• Serve as subject matter expert for specialized areas and complex studies, including GMO and MedTech
• Coach, mentor, supervise, and train junior staff
• Lead departmental improvement initiatives
• Contribute to business development through client meetings, bid defenses, design presentations, and strategic regulatory input during proposal development

Explore Regulatory Submissions Lead II at Premier Research. Review requirements and application details.

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