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

1. Provides high level strategic and operational direction of the Regulatory Submissions group within the Office of Clinical Research.
2. 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.
3. Ensures high-quality and timely delivery of IND/IDE regulatory submissions in compliance with all applicable regulatory requirements.
4. Ensures management and maintenance of all regulatory submissions in accordance with applicable regulatory requirements.
5. Acts as the liaison between FDA and the Institution. Develops a strong working relationship with the FDA.
6. Effectively addresses and resolves FDA questions and concerns, ensuring compliance and alignment with Institutions objectives.
7. 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.
8. Builds highly collaborative partnerships with key stakeholders, internal teams and clinical study teams. Ensure alignment of goals through the sharing of knowledge and expertise.
9. Serves as Regulatory Affairs representative for the Institution in meetings with external parties.
10. Maintains and develops standard operating procedures (SOPs) to ensure compliance with regulations, standards and current best practices.
11. Responsible for assisting with the development and implementation of regulatory processes.
12. Recruits, develops, manages, and mentors regulatory staff and helps create a supportive and growth-minded culture.

REQUIREMENTS

Required Education: Bachelor's Level Degree

Preferred Education: Master's Level Degree

Required Experience:

1. Ten (10) years of progressive experience in clinical research, regulatory affairs, and drug development.
2. Experience in developing and implementing regulatory strategies for investigational product development.
3. Five (5) years of leadership experience.

Preferred Experience:

Proven experience in working with regulatory authorities and navigating complex and matrix environments with multiple stakeholders.

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.

Additional Information

• Requisition ID: 170751
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 0
• Midpoint Salary: US Dollar (USD) 0
• Maximum Salary: US Dollar (USD) 0
• FLSA: exempt and not eligible for overtime pay
• Fund Type: Hard
• Work Location: Hybrid Onsite/Remote
• Relocation Assistance Available?: Yes