Senior Regulatory Lead, Clinical Trials (Hybrid)

Direct Jobs; West Hollywood (CA); Hybrid; USD 85,000 - 120,000; Full time

Job summary

Direct Jobs is seeking a Regulatory Coordinator III to supervise regulatory staff and manage submissions for clinical studies in Los Angeles. The role requires coordination with IRB, FDA, and other regulatory bodies, and ensuring rigorous documentation and timelines for trial activation.

The position follows a hybrid work schedule with in-person work in the Los Angeles area several times per week. A BA/BS degree and at least five years of related regulatory experience are required to apply.

Qualifications

• BA/BS degree required.
• Minimum of five years of directly related regulatory experience in clinical research.
• Experience with IRB, FDA, and GxP regulatory requirements.

Responsibilities

• Oversees daily regulatory activities and supervises Regulatory Coordinator I, II, and others.
• Prepares and submits protocols to IRB, FDA, PRMC, IACUC and related bodies.
• Submits continuations and amendments to maintain compliance with regulations.
• Responds to IRB/IACUC questions on regulatory aspects of studies.
• Maintains regulatory files and ensures up-to-date documentation for trials.

Skills

Regulatory coordination

Clinical research support

Regulatory submissions

Team supervision

Education

BA/BS degree

Job description

Direct Jobs is seeking a Regulatory Coordinator III to supervise regulatory staff and manage submissions for clinical studies in Los Angeles. The role requires coordination with IRB, FDA, and other regulatory bodies, and ensuring rigorous documentation and timelines for trial activation.

The position follows a hybrid work schedule with in-person work in the Los Angeles area several times per week. A BA/BS degree and at least five years of related regulatory experience are required to apply.