Senior Regulatory Submissions Lead

• 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, import/export licenses, and other regulatory applications for multi-region and complex studies
• Submit substantial and non-substantial modifications and required trial notifications through Clinical Study Reports
• Lead and execute EU interventional clinical study activities in CTIS, including overall regulatory submission strategy and Part I preparation and completion
• Serve as the primary regulatory and submissions lead for sponsors and project teams
• Align timelines, deliverables, submission strategies, document readiness, and regulatory requirements
• Identify and manage risks, issues, and contingency plans; escalate concerns and recommend resolutions
• Lead regulatory and submission discussions in kick-off meetings and internal/external study calls
• Prepare, review, and secure sponsor approval of core submission documents and country-specific packages
• Review IMPDs, protocols, Investigator's Brochures, informed consent forms, investigational product labels, and other regulatory materials
• Define Greenlight Package templates and coordinate country/site packages with Study Start-Up Associates
• Support country and site activation strategies with other functional areas
• Ensure operational excellence, compliance, quality execution, and financial oversight
• Monitor start-up budgets and contractual obligations and identify out-of-scope activities
• Serve as a subject matter expert in GMO, MedTech, and other regulatory domains
• Coach, mentor, supervise, and train junior staff
• Lead departmental improvement initiatives and contribute to business development through client meetings, bid defenses, design presentations, and proposal development

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus)
• 8–10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent
• Experience managing submissions for complex trials, different IP types, and different phases globally
• Experience managing the CTIS system
• Excellent knowledge of ICH/GCP regulations and applicable country-specific regulations
• Excellent knowledge of FDA Guidance Documents, EU Regulations, ISO 14155 regulations, drug/device development, and start-up procedures
• Ability to work accurately and interpret relevant directives and guidelines
• Ability to fulfill objectives and complete projects within agreed budgets and timelines
• Ability to multitask and work effectively in a fast-paced environment with changing priorities
• Excellent organizational and time-management skills, with ability to prioritize work to meet deadlines
• Accountable, dependable, and strongly committed to quality
• Customer-service-focused approach to internal and external work
• Available at short notice and set up to work as a freelancer/contractor

• Flexibility and balance to accommodate life requirements
• Freelance / contract opportunity offered as a full FTE for up to 6 months
• Opportunities for professional growth, skills development, and career advancement