Senior Regulatory Trials Lead – Oncology & Start-Up

Nicklaushealth; Miami (FL); On-site; USD 110,000 - 150,000; Full time

Job summary

Nicklaus Children's Research Institute seeks a Senior Research Regulatory Specialist to oversee regulatory strategy and submission readiness for a diverse portfolio of clinical trials. You will lead regulatory submissions, maintain audit-ready documents, and guide investigators and teams across multiple locations.

The role requires oncology trial experience, CTMS and eReg systems proficiency, and a strong focus on compliance, risk mitigation, and timely activation of new sites.

Qualifications

• Bachelor's Degree or 4 years clinical research experience.
• 4-7 years of experience in clinical research regulatory affairs and independent management of complex study portfolios.

Responsibilities

• Manage full lifecycle of regulatory submissions for complex trials.
• Serve as primary regulatory SME for assigned studies and ensure start-up readiness.
• Lead regulatory site activation and cross-functional coordination to secure approvals.

Skills

Independent work

Regulatory expertise

Oncology trials

Cross-location collaboration

Communication skills

Education

Bachelor's Degree

Clinical research experience

Tools

OnCore

Florence eTMF

REDCap

CTMS

Job description

Nicklaus Children's Research Institute seeks a Senior Research Regulatory Specialist to oversee regulatory strategy and submission readiness for a diverse portfolio of clinical trials. You will lead regulatory submissions, maintain audit-ready documents, and guide investigators and teams across multiple locations.

The role requires oncology trial experience, CTMS and eReg systems proficiency, and a strong focus on compliance, risk mitigation, and timely activation of new sites.