Regulatory Affairs Specialist

Job Summary

Providing regulatory expertise in a remote capacity, the full-time Regulatory Affairs Specialist will manage regulatory activities for clinical research studies, ensuring compliance with federal regulations, institutional policies, and Good Clinical Practices (GCP).

Key responsibilities

• Oversee regulatory submissions and documentation for clinical research studies, ensuring compliance with ICH/GCP and federal regulations
• Monitor and interpret changes in regulations and policies, providing guidance to stakeholders on regulatory requirements
• Collaborate with investigators and regulatory managers to develop and implement corrective and preventative action plans for compliance 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 GCP guidelines
• Ability to work independently and manage multiple complex studies
• Proficiency in Microsoft Office Suite and internet skills