Regulatory Affairs Specialist

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