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 is 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, 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.

This position offers the opportunity to lead high‑impact regulatory initiatives that directly support innovative cancer research and clinical trials at UT MD Anderson. As part of a highly collaborative and mission‑driven environment, this role enables professional growth while contributing to advancements in oncology care, scientific discovery, and regulatory excellence in a fast‑paced research setting.

• Employer‑paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
• Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
• Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
• Defined‑benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer‑paid life and reduced salary protection programs.

• Develop targeted regulatory strategies for oncology programs across early‑ and late‑phase clinical trials.
• Conduct regulatory assessments of drug and device trials to determine exemption eligibility and risk levels.
• Monitor evolving regulatory requirements and assess impact on ongoing and planned oncology programs.
• Implement process improvements to enhance regulatory effectiveness and compliance.

• Serve as primary regulatory liaison with the FDA for submissions, communications, and inquiries.
• Coordinate responses to FDA information requests and regulatory submissions.
• Participate in FDA meetings including pre‑IND and Type B/C meetings.
• Provide regulatory guidance to investigators and study teams on requirements, timelines, and compliance.

• Align regulatory activities with clinical, scientific, manufacturing, and quality stakeholders.
• Lead regulatory document management ensuring accuracy, completeness, and audit readiness.
• Oversee preparation and maintenance of clinical protocols and regulatory submission documents.
• Review institutional policies, SOPs, and training related to FDA‑regulated research.
• Direct staff development and provide leadership to regulatory affairs team members.

• Ensure compliance with FDA regulations…