Senior Regulatory Lead, Cancer Trials

Oncology Voice Network LLC; Florida; On-site; USD 95,000 - 135,000; Full time

Job summary

Nicklaus Children's Hospital is seeking a Senior Regulatory Specialist to oversee complex regulatory submissions, ensure compliance, and guide study start-up for a multi-site oncology portfolio. The role emphasizes collaboration with investigators, sponsors, and internal stakeholders to maintain audit readiness and submission timeliness.

The candidate will manage CTMS and electronic regulatory systems, support audits, and mentor junior staff while advancing regulatory strategy across multiple

Qualifications

• Bachelor's Degree (or 4 years clinical research experience) is required.
• 4-7 years of experience in clinical research regulatory affairs with progressive responsibilities.
• ACRP or CCRP certification preferred.
• Experience with oncology clinical trials and NCTN trials.
• Proficiency with CTMS (OnCore) and electronic regulatory binders (Florence eTMF).

Responsibilities

• Independently manages full lifecycle of regulatory submissions for complex trials.
• Serves as SME on regulatory strategy, risk mitigation, and start-up readiness.
• Leads site activation and start-up activities across multiple locations.
• Maintains electronic regulatory binders and essential documents (FDA 1572, disclosures, logs).
• Participates in audits and supports sponsor/IRB/IBC submissions.
• Mentors junior regulatory staff and supports process improvements.

Skills

Regulatory submissions

Phase 1 clinical trials

CTMS proficiency

REDCap experience

Independent work

Cross-functional coordination

Education

Bachelor's Degree

ACRP/CCRP certification

Tools

OnCore

Florence eTMF

CTMS

Microsoft Office

Job description

Nicklaus Children's Hospital is seeking a Senior Regulatory Specialist to oversee complex regulatory submissions, ensure compliance, and guide study start-up for a multi-site oncology portfolio. The role emphasizes collaboration with investigators, sponsors, and internal stakeholders to maintain audit readiness and submission timeliness.

The candidate will manage CTMS and electronic regulatory systems, support audits, and mentor junior staff while advancing regulatory strategy across multiple