Remote Assistant Director, Regulatory Affairs - Trials

Yale University; New Haven (CT); On-site; USD 105,000 - 174,000; Full time

Job summary

Yale University seeks an Assistant Director, Regulatory Affairs to lead the CTO regulatory division. You will oversee regulatory managers, specialists, and assistants, shaping workflows, policies, and training to ensure compliance with federal regulations and institutional standards.

You will manage audit responses, implementation of corrective actions, and collaboration across CTO leadership to optimize activation timelines for clinical trials at Yale Cancer Center.

Qualifications

• Knowledge of federal regulations governing human subjects research (FDA, ICH GCP, OHRP, HIPAA).
• Ability to supervise and mentor regulatory staff and optimize resources.
• Strong communication, leadership, and problem-solving skills.

Responsibilities

• Direct regulatory department and oversee regulatory teams within CTO.
• Develop workflows, policies, and training to ensure compliance.
• Lead responses to audits and implement corrective actions.
• Drive timelines for protocol activation and regulatory processes.

Skills

Regulatory leadership

GCP & HIPAA expertise

Staff supervision

Regulatory operations

FDA audits

Education

Bachelor’s degree in related field

Eight years of experience

Master’s degree preferred

Job description

Yale University seeks an Assistant Director, Regulatory Affairs to lead the CTO regulatory division. You will oversee regulatory managers, specialists, and assistants, shaping workflows, policies, and training to ensure compliance with federal regulations and institutional standards.

You will manage audit responses, implementation of corrective actions, and collaboration across CTO leadership to optimize activation timelines for clinical trials at Yale Cancer Center.