Senior Regulatory Coordinator

Job Summary

A company is looking for a Senior Regulatory Coordinator to manage regulatory requirements for clinical research projects.

Key Responsibilities

• Coordinate protocol submissions and prepare regulatory documents to ensure compliance with regulations
• Track and manage new protocol start-up processes and maintain communication with key stakeholders
• Assist with regulatory training and present regulatory status at research meetings

Required Qualifications

• Bachelor's degree required; Master's or advanced degree preferred
• 3+ years of direct regulatory experience required
• Expert knowledge of FDA and ICH/GCP guidelines
• Previous experience with clinical trials and personnel management required
• Proficient in Microsoft applications and databases