Remote Oncology Regulatory Affairs Director

UT MD Anderson; Houston (TX); On-site; USD 70,000 - 106,000; Full time

Job summary

UT MD Anderson Cancer Center seeks a Director of Clinical Research Regulatory Affairs to lead oncology regulatory strategy for IND/IDE submissions, advise investigators, and coordinate FDA interactions. This role demands strong leadership, advanced FDA/ICH/GCP knowledge, and effective cross-functional collaboration across clinical research, manufacturing, and quality groups.

The position emphasizes governance, audit readiness, and staff development within a remote-capable, regulation-focused

Qualifications

• Required: Bachelor's degree Life sciences, pharmacy, medicine, or a related field.
• Preferred: Master's degree Life sciences, pharmacy, medicine, or related field.
• Eight years Regulatory affairs experience with FDA submissions in oncology and two years lead project management.

Responsibilities

• Develop targeted regulatory strategies for oncology programs across early- and late-phase trials.
• Conduct regulatory assessments to determine exemption eligibility and risk levels.
• Monitor evolving regulatory requirements and assess impact on programs.
• Implement process improvements to enhance regulatory effectiveness and compliance.
• Serve as primary regulatory liaison with the FDA for submissions and inquiries.
• Coordinate responses to FDA information requests and regulatory submissions.
• Lead regulatory document management, ensuring audit readiness.
• Oversee preparation and maintenance of clinical protocols and submission documents.
• Review institutional policies, SOPs, and training related to FDA-regulated research.
• Direct staff development and provide leadership to regulatory affairs team.

Skills

Regulatory strategy

Leadership

Communication

Project management

FDA regulations

Education

Bachelor's degree Life sciences

Master's degree Life sciences

Job description

UT MD Anderson Cancer Center seeks a Director of Clinical Research Regulatory Affairs to lead oncology regulatory strategy for IND/IDE submissions, advise investigators, and coordinate FDA interactions. This role demands strong leadership, advanced FDA/ICH/GCP knowledge, and effective cross-functional collaboration across clinical research, manufacturing, and quality groups.

The position emphasizes governance, audit readiness, and staff development within a remote-capable, regulation-focused