[Hiring] Senior Regulatory Submissions Lead @Premier Research

Role Description

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.

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 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, ensuring alignment on timelines, deliverables, and regulatory requirements.
• Proactively identify, communicate, and manage risks, issues, and contingency plans; escalate critical concerns.
• Own submission documentation and regulatory content quality by preparing, reviewing, and securing sponsor approval of core submission documents.
• Review essential clinical and regulatory documents to ensure compliance, completeness, quality, and country-specific acceptability requirements.
• 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).
• 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 managing CTIS system.
• 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.
• Ability to work accurately and interpret relevant directives and guidelines.
• Ability to fulfill objectives and complete projects within the agreed budget and timelines.
• 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.

Benefits

• Annualized minimum base pay for this role is $145,000.00 USD.
• Actual salary influenced by qualifications, skills, competencies, and proficiency for the role.
• Comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.

Company Description

Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.