Regulatory Affairs Specialist

Job Summary

Serving as the primary specialist on regulatory affairs processes for clinical research studies, the full-time remote Regulatory Affairs Specialist will manage regulatory activities, ensure compliance with FDA regulations and GCP guidelines, and collaborate with investigators to maintain high standards in clinical research documentation.

Key responsibilities

• Manages, implements, and evaluates all aspects of regulatory activities, including submissions and responses throughout the study lifecycle
• Monitors and interprets federal and state regulations, ensuring compliance with institutional policies and procedures
• Collaborates with investigators to prepare and execute corrective action plans and participates in audits and inspections for clinical research studies

Required qualifications

• Bachelor's degree in life sciences or a related health discipline
• Minimum of two years of clinical research support experience
• Proficiency in Microsoft Office Suite and internet skills
• Knowledge of FDA regulations and Good Clinical Practice guidelines
• Ability to work independently and manage multiple tasks in a fast-paced environment