Oncology Regulatory Affairs Director (Remote)

University of Texas MD Anderson Cancer Center; Houston, Northern (TX, KY); Hybrid; USD 147,000 - 220,000; Full time

Benefits offered by this job

Employer-paid medical coverage

Paid time off

Tuition assistance

Pension plan

Job summary

University of Texas MD Anderson Cancer Center seeks a Director of Clinical Research Regulatory Affairs to lead regulatory strategy for oncology programs, INDs, IDEs, and FDA interactions, ensuring timely and compliant submissions.

This senior role partners with investigators, sponsors, and cross-functional teams to drive governance, program risk assessments, and audit-ready documentation in a remote-capable environment.

Qualifications

• Bachelor's degree in life sciences, pharmacy, medicine, or related field.
• Master's degree in life sciences or related field preferred.
• Eight years of regulatory affairs experience with FDA submissions, oncology focus, and lead PM experience.
• Experience with INDs/IDEs and FDA interactions; RAC is a plus.

Responsibilities

• Develop regulatory strategies for oncology programs across trials and devices.
• Coordinate FDA submissions, information requests, and meetings.
• Lead regulatory governance, document management, and training.
• Ensure compliance with FDA, ICH, and GCP across projects.

Skills

Regulatory strategy

FDA submissions

Regulatory leadership

Project management

Education

Bachelor's degree in life sciences/related field

Master's degree preferred

Job description

University of Texas MD Anderson Cancer Center seeks a Director of Clinical Research Regulatory Affairs to lead regulatory strategy for oncology programs, INDs, IDEs, and FDA interactions, ensuring timely and compliant submissions.

This senior role partners with investigators, sponsors, and cross-functional teams to drive governance, program risk assessments, and audit-ready documentation in a remote-capable environment.