Regulatory Affairs Manager

Job Summary

Managing Oncology Disease Group regulatory affairs teams, the full-time remote Regulatory Affairs Manager will ensure compliance with clinical trials regulatory requirements, oversee staff performance and recruitment, and collaborate with multidisciplinary teams to support clinical research protocols.

Key responsibilities

• Manage and monitor policies, practices, and procedures of regulatory affairs staff involved in clinical research studies
• Recruit, hire, train, and supervise regulatory affairs professionals while tracking personnel resource allocation based on study parameters
• Collaborate with Clinical Research Managers and Principal Investigators to assess complex clinical trial protocols and prepare for regulatory audits

Required qualifications

• Bachelor's degree in a health-related discipline
• Minimum of seven years of clinical research experience, including five years in regulatory affairs
• Strong knowledge of Good Clinical Practice guidelines and federal regulations
• Proven ability to lead and execute complex projects effectively
• Experience with oncology clinical trials is strongly preferred