Regulatory Specialist

**
* Please note:

This position is onsite and not remote. Candidates must be based in the Orange, CA area, as relocation assistance is not provided. Only individuals authorized to work in the U.S. will be considered.***

• Job Title: Regulatory Specialist (Part-Time)
• Job Type: Part-Time | On-Site
• Job Location: Orange, CA
• Job Salary: $27.00-$30.00/hour
  * based on experience*
• Industry: Clinical Research | Hepatology | Phase I–IV Trials

Our client is a fast-paced, compliance-driven research clinic specializing in liver disease trials—from NASH and cirrhosis to hepatocellular carcinoma. Our team partners with leading sponsors and CROs to deliver high-quality, audit-ready data and compassionate patient care.

We are seeking a detail‑oriented Regulatory Specialist with 2+ years of experience in clinical research regulatory operations. This part‑time, on‑site role supports regulatory submissions, document maintenance, compliance tracking, and study start‑up activities. The ideal candidate is organized, proactive, and comfortable working in a deadline‑driven environment.

This role is expected to report on‑site three days per week, with some flexibility depending on operational needs.

• Prepare, submit, and track regulatory documents for IRB/IEC submissions, amendments, continuing reviews, and study closeouts
• Maintain regulatory binders, essential documents, and version control in accordance with ICH‑GCP, FDA, and site SOPs
• Support study start‑up activities including feasibility documentation, delegation logs, and training records
• Communicate with sponsors, CROs, and IRBs to ensure timely responses and document updates
• Assist with audit readiness and regulatory inspections by maintaining accurate, complete, and compliant documentation
• Coordinate with clinical and administrative teams to ensure regulatory timelines are met
• Maintain compliance with HIPAA, GCP, and institutional policies

• 2+ years of regulatory experience in a clinical research setting (required)
• Strong understanding of FDA, ICH‑GCP, and IRB regulatory requirements
• Experience preparing and submitting regulatory packets and essential documents
• Excellent organizational skills and attention to detail
• Strong written and verbal communication abilities
• Proficiency with Microsoft Office and common clinical research platforms (CTMS, eReg, eTMF preferred)
• Ability to work independently and manage multiple deadlines

• Experience in a clinical research site environment
• Familiarity with California‑specific regulatory requirements
• Prior experience supporting audits or inspections

• Entry level

• Part-time

• Legal

• Human Resources Services