Regulatory Submissions Lead II

This is a fully remote position, open to applicants in Spain, +4 more countries.

📋 Description

• Lead and implement regulatory strategies, submissions, and approvals across participating countries throughout the research lifecycle.

• Develop and oversee regulatory and start-up project plans.

• Coordinate and submit Clinical Trial Applications to relevant regulatory authorities, along with import/export licenses and other regulatory applications.

• Submit both substantial and non-substantial modifications and necessary trial notifications for maintenance studies.

• Oversee and carry out EU interventional clinical study activities in CTIS, including the overall submission strategy and completion of Part I.

• Serve as the primary regulatory and submissions leader 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 suggest resolutions.

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

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

• Review clinical and regulatory documents to ensure compliance, completeness, quality, and adherence to country-specific standards.

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

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

• Ensure high-quality and compliant regulatory and start-up execution.

• Monitor study start-up budgets and contractual obligations while identifying out-of-scope activities.

• Act as a subject matter expert for specialized areas and complex studies, including GMO and MedTech.

• Coach, mentor, supervise, and train junior staff members.

• Lead initiatives aimed at departmental improvement.

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

⛳️ Requirements

• University degree level education.

• Practical experience with Part I and Part II submissions in CTIS.

• 8–10 years of experience, with 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, various IP types, and different phases on a global scale.

• Experience in MD/IVDR and GMO is highly recommended.

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

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

• Ability to collaborate effectively and build a cohesive team.

• Capable of multitasking efficiently in a dynamic environment with shifting priorities.

• Exceptional organizational and time-management skills; able to prioritize tasks and meet deadlines.

• Demonstrates accountability, dependability, and a strong commitment to quality.

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

🏝️ Benefits

• Flexibility and balance to support your personal life.

• Skills and opportunities for professional development.

• Opportunities for coaching, mentoring, supervision, and training.

• Participation in initiatives aimed at departmental improvement.

• Contribution to business development efforts.