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 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.

Responsibilities

Oncology Regulatory Strategy and Assessment
• 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

Regulatory Liaison & FDA Interactions
• 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

Institutional Governance & Leadership
• 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

Regulatory Operations & Compliance
• Ensure compliance with FDA regulations (21 CFR 312, 812), ICH guidelines, and GCP requirements
• Support regulatory activities for investigational drugs, biologics, and devices including INDs and IDEs
• Manage multiple complex regulatory projects simultaneously with strong project management discipline
• Maintain high standards of documentation, reporting, and inspection readiness

Other duties as assigned

EDUCATION
• Required: a Bachelor's Degree Life sciences, pharmacy, medicine, or a related field
• Preferred: a Master's Degree Life sciences, pharmacy, medicine, or a related field

WORK EXPERIENCE
• Required: Eight years Regulatory affairs experience with FDA submissions, and oncology clinical research to include two years lead project management experience
• Preferred: Demonstrated experience preparing and managing INDs and/or IDEs; familiarity with companion diagnostics and combination products is a plus, and an in-depth knowledge of FDA regulations, FDA submissions, ICH guidelines, and GCP requirements, and an experience with EMA submissions
• Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience Completion of both programs can be substituted for a maximum of two years of supervisory or management experience

LICENSES AND CERTIFICATIONS
• Preferred: RAC - Regulatory Affairs Cert

The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.

This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.