Senior Regulatory Submissions Lead (Clinical Trials)

Location: Spain; hiring location may be flexible

Company

hirify.global supports biotech, medtech, and specialty pharmaceutical organizations in developing medicines, medical devices, and diagnostics.

What you will do

• Lead regulatory strategies, submissions, and approvals across participating countries throughout the clinical study lifecycle.
• Coordinate Clinical Trial Applications, ethics and regulatory submissions, import/export licenses, trial notifications, modifications, and other regulatory applications.
• Lead EU interventional study activities in the Clinical Trial Information System (CTIS), including the overall submission strategy and Part I preparation.
• Act as the primary regulatory and submissions lead for sponsors and project teams, managing timelines, deliverables, risks, issues, and contingency plans.
• Prepare, review, and secure approval for core submission documents and country-specific packages while ensuring regulatory quality and compliance.
• Drive country and site start-up readiness, monitor budgets and contractual obligations, and provide subject-matter expertise, mentoring, and business development support.

Requirements

• University degree; pharmacy, medicine, or a related natural science degree is advantageous.
• 8–10 years of relevant experience, including at least 6 years as a Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent.
• Experience managing complex global trial submissions across different investigational product types and development phases.
• Experience managing the CTIS system and strong knowledge of ICH/GCP, FDA guidance, EU regulations, ISO 14155, drug and device development, and start-up procedures.
• Strong organizational, time-management, communication, collaboration, and prioritization skills, with a commitment to quality and accountability.
• Available to work from Spain or another agreed hiring location and set up to work as a freelancer or contractor.

Nice to have

• Experience with GMO, medtech, or other specialized regulatory domains.
• Experience coaching, mentoring, supervising, or training junior staff.

Culture & Benefits

• Freelance or contract engagement at full FTE capacity for up to one year.
• Flexible hiring location and consideration for candidates available at short notice.
• Opportunities to contribute ideas, process improvements, and departmental initiatives.
• Support for professional growth, skills development, flexibility, and work-life balance.