Director, Clinical Research Regulatory Affairs

UT MD Anderson Cancer Center • Houston, TX

5d • Onsite

About The Position

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.

Requirements

• A Bachelor's Degree Life sciences, pharmacy, medicine, or a related field
• Eight years Regulatory affairs experience with FDA submissions, and oncology clinical research
• Two years lead project management experience
• Must pass pre-employment skills test as required and administered by Human Resources

Nice To Haves

• Master’s degree in a life sciences, pharmacy, medicine, or related field
• 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
• RAC certification
• Demonstrated leadership and communication skills in complex research environments
• Demonstrated experience preparing and managing INDs and/or IDEs
• Familiarity with companion diagnostics and combination products is a plus
• In-depth knowledge of FDA regulations, ICH guidelines, and GCP requirements
• 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

Responsibilities

• 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 (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

Benefits

• Employer-paid medical coverage starting day one for employees working 30+ hours/week
• Optional group dental, vision, life, AD&D, and disability insurance
• Accruals for PTO and Extended Illness Bank
• Paid holidays
• Wellness, childcare, and other leave options
• Tuition Assistance Program after six months of service
• Access to extensive wellness, fitness, and employee resource groups
• Defined-benefit pension through the Teachers Retirement System
• Voluntary retirement plans
• Employer-paid life and reduced salary protection programs
• Medical
• Dental
• Paid time off
• Retirement
• Tuition benefits
• Educational opportunities
• Individual and team recognition

What This Job Offers

• Job Type: Full-time
• Career Level: Director