[Hiring] Regulatory Submissions Lead II @Premier Research

Role Description

Premier Research is looking for a Regulatory Submissions Lead II 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.
• Develop and manage regulatory and start-up project plans; coordinate and submit Clinical Trial Applications (CTAs) to all applicable regulatory bodies.
• Ensure timely submission of substantial and non-substantial modifications, and all required trial notifications for maintenance studies.
• Directly lead and execute activities within the Clinical Trial Information System (CTIS) for EU interventional clinical studies.
• Act as the primary regulatory & submissions lead for sponsors and project teams.
• Proactively identify, communicate, and manage risks, issues, and contingency plans.
• Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents.
• Drive start-up readiness by defining and agreeing Greenlight Package templates with sponsors.
• Maintain operational excellence, compliance, and financial oversight by ensuring high-quality execution of all regulatory and start-up activities.
• Provide leadership, expertise, and business support by serving as a subject matter expert in specialized areas and complex studies.

Qualifications

• Education to university degree level (pharmacy, medicine or related natural sciences are a plus).
• Hands-on experience with Part I and Part II submissions in CTIS.
• 8-10 years' experience, including at least 6 years' experience as Regulatory Submissions Lead, Start-Up Lead, Submissions Manager, or equivalent.
• Experience in managing submission of complex trials, different IP types and different phases, globally.
• Experience in MD/IVDR and GMO is highly recommended.
• Excellent knowledge of ICH/GCP regulations/country specific regulations as applicable.
• Excellent knowledge of FDA Guidance Documents/EU Regulations/ISO14155 regulations, drug/device development, and start-up procedures.
• Excellent team player, collaborative and able to build an effective team.
• Ability to multitask and work effectively in a fast-paced environment with changing priorities.
• Excellent organizational and time-management skills, able to prioritize work to meet deadlines.
• Accountable, dependable and strong commitment to quality.
• Customer service focused approach to work both internally and externally.