Director, FDA Submissions

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

This position will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and applications. They will oversee a team of regulatory specialists responsible for advising MD Anderson's investigators on FDA submission requirements and pathways, develop investigational plans and protocols, FDA applications writing and submission services, and IND/IDE lifecycle management. The incumbent will serve as MD Anderson's (sponsor) representative for all FDA related communication and interactions.

JOB SPECIFIC COMPETENCIES

Provides high level strategic and operational direction of the Regulatory Submissions group within the Office of Clinical Research. 

Leads and advises regulatory and clinical study teams, providing expert guidance for regulatory activities including overall regulatory strategy, regulatory requirements for clinical studies, regulatory submission preparation and maintenance.

Ensures high-quality and timely delivery of IND/IDE regulatory submissions in compliance with all applicable regulatory requirements

Ensures management and maintenance of all regulatory submissions in accordance with applicable regulatory requirements. 

Acts as the liaison between FDA and the Institution. Develops a strong working relationship with the FDA.

Effectively addresses and resolves FDA questions and concerns, ensuring compliance and alignment with Institutions objectives

Analyzes and communicates current regulatory guidance and regulations, as well as industry and FDA best practices and trends, to keep Institution informed on any relevant changes in the regulatory landscape

Builds highly collaborative partnerships with key stakeholders, internal teams and clinical study teams. Ensure alignment of goals through the sharing of knowledge and expertise

Serves as Regulatory Affairs representative for the Institution in meetings with external parties

Maintains and develops standard operating procedures (SOPs) to ensure compliance with regulations, standards and current best practices

Responsible for assisting with the development and implementation of regulatory processes

Recruits, develops, manages, and mentors regulatory staff and helps create a supportive and growth-minded culture