Senior Regulatory Submissions Lead

This is a fully remote position, open to applicants in Spain, +7 more countries.

📋 Description

• Oversee and implement regulatory strategies, submissions, and approvals across all participating countries throughout the study lifecycle.

• Create and manage regulatory and start-up project plans.

• Coordinate and submit Clinical Trial Applications to relevant regulatory bodies, import/export licenses, and other regulatory applications for intricate, multi-region studies.

• Submit both substantial and non-substantial modifications along with necessary trial notifications through Clinical Study Reports.

• Direct and execute EU interventional clinical study activities in CTIS, including the overall regulatory submission strategy and the preparation and completion of Part I.

• Serve as the 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 propose resolutions.

• Lead regulatory and submission discussions during kick-off meetings and both internal and external study calls.

• Prepare, review, and secure sponsor approval for core submission documents and country-specific submission packages.

• Review IMPDs, protocols, Investigator’s Brochures, informed consent forms, investigational product labels, and other regulatory materials to ensure compliance, completeness, quality, and country-specific acceptability.

• Define Greenlight Package templates and coordinate country/site greenlight packages with Study Start-Up Associates.

• Support country and site activation strategies in collaboration with other functional areas.

• Ensure quality execution, regulatory compliance, process enhancement, budget oversight, and monitoring of contractual obligations.

• Act as a subject matter expert in GMO, MedTech, and other regulatory domains.

• Mentor, coach, supervise, and train junior staff.

• Lead initiatives for departmental improvements.

• Contribute to business development through client meetings, bid defenses, design presentations, and strategic regulatory input during proposal development.

⛳️ Requirements

• A university degree (pharmacy, medicine, or related natural sciences is advantageous).

• 8–10 years of experience, including a minimum of 6 years in roles such as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent.

• Proven experience managing submissions for complex trials involving various IP types and phases on a global scale.

• Familiarity with managing the CTIS system.

• Strong knowledge of ICH/GCP regulations and applicable country-specific regulations.

• In-depth understanding of FDA Guidance Documents, EU Regulations, ISO 14155 regulations, drug/device development, and start-up processes.

• Capability to work accurately and interpret relevant directives and guidelines.

• Proven ability to achieve objectives and complete projects within agreed budgets and timelines.

• Strong collaborative skills and the ability to build effective teams.

• Ability to multitask and perform effectively in a fast-paced environment with shifting priorities.

• Excellent organizational and time-management skills; ability to prioritize tasks to meet deadlines.

• Accountable, reliable, and deeply committed to quality.

• Customer-service-oriented approach for both internal and external interactions.

• Availability at short notice is encouraged.

• Prepared to work as a freelancer/contractor.

🏝️ Benefits

• Flexibility and balance to support personal life requirements.

• Opportunities for growth, skills enhancement, and career development.

• Freelance/contract engagement for a duration of up to 1 year.

• Full FTE arrangement.

• Flexible hiring location.