The National Institute of Clinical Research, a leading research organization serving the pharmaceutical and biotechnology industries, is seeking a Clinical Trials Regulatory Specialist with 2 or more years of experience, to join our team.

We are looking for a skilled and motivated individual responsible for preparing, reviewing, and maintaining regulatory documents and submissions to ensure full compliance with FDA regulations, ICH-GCP guidelines, and sponsor requirements. This role plays a critical part in supporting clinical trial start-up, maintenance, and close-out activities, ensuring all required documentation is accurate, complete, and submitted in a timely manner.

Responsibilities include:

Prepare and submit regulatory documents (e.g., 1572s, CVs, financial disclosures, protocol submissions, IRB submissions, etc.) for clinical studies.

Track and maintain essential regulatory documents in accordance with sponsor and regulatory requirements.

Communicate with Institutional Review Boards (IRBs), sponsors, and internal departments to ensure regulatory compliance and timely approvals.

Maintain Trial Master File (TMF)/Investigator Site File (ISF) and ensure inspection-readiness.

Monitor study timelines and proactively manage submission deadlines and expirations.

Support study start-up and close-out activities by coordinating required documentation.

Assist with audits and inspections as needed.

Stay current with relevant regulations, guidelines, and industry best practices.

Qualifications:

Bachelor’s degree in Life Sciences, Healthcare, or related field preferred.

Minimum of 2 years of regulatory experience in a clinical research setting.

Knowledge of FDA regulations, ICH-GCP, and clinical research protocols.

Strong organizational skills and attention to detail.

Excellent written and verbal communication skills.

Proficiency with Microsoft Office Suite and electronic regulatory systems.

Preferred Skills:

Experience working with IRBs and regulatory agencies.

Familiarity with CTMS or electronic document management systems.

Clinical Research Coordinator (CRC) or Regulatory Affairs Certification (RAC) is a plus.

Candidates must be local to Orange County, CA area

Location

Garden Grove, CA

Full-time

This is not a remote position

Benefits

Medical Insurance, Dental & Vision Insurance, 401k, PTO