Connecticut Licensed Regulatory Specialist

Job Summary

Managing regulatory activities for clinical research studies, the full-time Connecticut Licensed Regulatory Specialist will oversee the study portfolio, ensure compliance with federal regulations and institutional policies, and provide regulatory expertise while working remotely from Connecticut.

Key responsibilities

• Oversees regulatory processes for clinical research, ensuring compliance with ICH/GCP and federal regulations
• Monitors and assesses changes in regulations and their impact on the regulatory affairs department
• Mentors junior regulatory staff and collaborates with investigators and stakeholders to enhance compliance and operational efficiency

Required qualifications

• Bachelor's degree in life sciences or a related health discipline
• Minimum of three years of experience in regulatory affairs support
• Advanced knowledge of FDA regulations and Good Clinical Practice guidelines
• Experience in managing multiple complex clinical studies
• Proficiency in Microsoft Office Suite and internet research skills