Regulatory Specialist - job 1 of 2

Job Summary

A company is looking for a Regulatory Specialist.

Key Responsibilities

• Maintain regulatory start-up and ongoing documentation throughout clinical trials
• Ensure compliance with all IRB-approved protocols, sponsor requirements, and applicable regulations
• Collaborate with internal teams and external sponsors to facilitate effective communication and issue resolution

Qualifications

• Bachelor's degree in life sciences, healthcare, or related field (preferred)
• 2+ years of experience in clinical research regulatory affairs or a similar role
• Strong understanding of GCP, ICH guidelines, FDA regulations, and IRB processes
• Ability to manage multiple priorities and deadlines
• Detail-oriented with excellent organizational skills