Regulatory Affairs Assistant Director

Job Summary

Reporting to the Director of Operations at the Clinical Trials Office, the full-time remote Regulatory Affairs Assistant Director will oversee regulatory teams, develop workflows and policies, ensure compliance with regulations, and manage the operational functions of the regulatory division within the Yale Cancer Center.

Key responsibilities

• Directs and oversees the centralized regulatory team's functions for the Clinical Trials Office
• Develops and implements regulatory processes, policies, and workflows to support clinical research compliance
• Manages daily operations and staff development for the regulatory division, ensuring effective training and performance assessment

Required qualifications

• Bachelor's Degree in a related field and eight years of relevant experience
• Expert knowledge of federal regulations governing human subjects research, including FDA and GCP guidelines
• Demonstrated ability to supervise and develop regulatory staff in a collaborative team environment
• Advanced communication and leadership skills with a proven track record in problem-solving and decision-making
• Experience in managing multiple projects in multidisciplinary environments