Premier Research is looking for a Senior Regulatory Submissions Lead to join our Regulatory Submissions and Contracts team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
- We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
- Your ideas influence the way we work, and your voice matters here.
- As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

· Lead and execute regulatory strategy, submissions, and approvals across all participating countries throughout the study lifecycle by developing and managing regulatory and start-up project plans; coordinating and submitting Clinical Trial Applications (CTAs)



to all applicable regulatory bodies (Ethics Committee, Institutional Review Boards, Competent Authorities (CA, CEC/CIRB, LEC/LIRB)), import/export licenses, and other regulatory applications for multi-region and complex studies in start-up. For maintenance studies, ensures timely submission of substantial and non-substantial modifications, and all required trial notifications, including first patient in, end of trial, temporary halts and early terminations until Clinical Study Reports. For EU interventional clinical studies, directly lead and execute activities within the Clinical Trial Information System (CTIS), owning the development of the overall regulatory submission strategy as well as the preparation and completion of the Part I.

· Act as the primary regulatory & submissions lead for sponsors and project teams, ensuring alignment on timelines, deliverables, submission strategies, document rea

📌 Senior Regulatory Submissions Lead (España)
🏢 Premier Research
📍 España