Regulatory Affairs Specialist

Job Summary

Working remotely, the full-time Regulatory Affairs Specialist will manage regulatory activities for clinical research, ensuring compliance with federal regulations and Good Clinical Practices while collaborating with investigators and stakeholders.

Key responsibilities

• Oversee regulatory processes for clinical research studies, including submissions and compliance with ICH/GCP and federal regulations
• Monitor and interpret changes in regulations, providing guidance and recommendations based on analysis of clinical trial protocols
• Collaborate with investigators to develop and implement corrective and preventative action plans for noncompliance issues

Required qualifications

• Bachelor's degree in life sciences or a related health discipline
• Minimum of two years of clinical research support experience
• Knowledge of FDA regulations and Good Clinical Practice guidelines
• Ability to work independently and manage complex studies with minimal supervision
• Proficiency in Microsoft Office Suite and internet skills