Director, Clinical Research Regulatory Affairs

UT MD Anderson has the nation's largest cancer clinical trials program enrolling patients in Texas and beyond through our Cancer Network® partners across the country. UT MD Anderson is devoted to the needs and protection of all those participating in or conducting clinical research while maintaining high ethical standards and compliance with all regulatory policies. The Division of Clinical Research provides infrastructure support for all aspects of clinical research.

The Director, Clinical Research Regulatory Affairs position is responsible for overseeing the Institution's regulatory activities related to FDA submissions in support of oncology clinical research and product development at MD Anderson. The Director, Clinical Research Regulatory Affairs part of a team responsible for regulatory advice and strategy related to investigational products and assets. The candidate is expected to provide regulatory strategy and operational leadership for investigational drugs, biologics, and devices, including INDs, IDEs, and associated amendments, and ensure compliance with FDA regulations and institutional policies. This position serves as a key regulatory partner to investigators, sponsors, and cross-functional teams to facilitate efficient development and conduct of cancer clinical trials.

The ideal candidate brings a preferred Master's degree in a life sciences, pharmacy, medicine, or related field, along with extensive experience in oncology regulatory affairs, including IND and IDE submissions, FDA interactions, FDA submissions and EMA exposure. Strong project management expertise, advanced knowledge of FDA regulations and ICH/GCP guidelines, and a preferred RAC certification distinguish this candidate, along with demonstrated leadership and communication skills in complex research environments.

Minimum $70.43 - Midpoint $87.98 - Maximum $105.53

Location: Remote

Why Us?

This position offers the opportunity to lea