Senior Regulatory Affairs Specialist

Job Summary

Leading regulatory activities for clinical research protocols, the full-time remote Senior Regulatory Affairs Specialist will manage study start-up, submissions, and compliance for investigator-initiated trials while mentoring junior staff and improving regulatory processes.

Key responsibilities

• Oversee regulatory affairs processes for clinical research studies, ensuring compliance with federal regulations and Good Clinical Practice (GCP) guidelines
• Provide regulatory leadership and mentorship to junior regulatory affairs staff, promoting best practices and operational efficiency
• Collaborate with investigators and management to prepare for audits and monitor compliance, implementing corrective actions as necessary

Required qualifications

• Bachelor's degree in life sciences or a related health discipline
• Minimum of five years of experience in regulatory affairs support
• Extensive knowledge of FDA regulations and GCP guidelines
• Proficiency in Microsoft Office Suite and internet skills
• Ability to manage multiple high-acuity clinical trials concurrently