Senior Clinical Regulatory Specialist
Core
Senior Clinical Regulatory Specialist supporting compliant execution of Phase 2–4 industry-sponsored clinical trials across a global research network.
Role type
Senior Clinical Regulatory Specialist
Builds
Regulatory compliance and operational efficiency for clinical trials
Domain
Clinical Research / Healthcare / Regulatory Affairs
Deliverable
client delivery
Required skills
GCP knowledge, FDA regulations expertise, IRB processes, regulatory documentation review, risk identification, stakeholder management, process improvement, CTMS proficiency
Preferred skills
Mentoring experience, electronic regulatory platform experience, eSource experience
Responsibilities
Oversee regulatory activities across study lifecycle (start-up, activation, maintenance, closeout), review and QC regulatory submissions, manage IRB applications and safety reports, identify and escalate compliance risks, mentor site teams, support inspection readiness, drive process improvements
Seniority
Senior, hands-on IC
