Professor of Practice, Regulatory Affairs, Henry E. Riggs School of Applied Life Sciences

About the role

The successful candidate will join the Henry E. Riggs School of Applied Life Sciences at KGI (Riggs) conducting teaching and curriculum development in regulatory affairs. The Riggs School prioritizes teaching and research, providing an interdisciplinary perspective on drug development, supplementing clinical and regulatory courses with science and business courses tailored to careers in pharmaceutical companies.

Responsibilities

• Provide vision and oversight for the design, implementation and evaluation of clinical and regulatory curriculum.
• Work with potential partner sites to align curriculum and rotations to each other and to program outcomes.
• Work with other KGI faculty to coordinate the content and delivery of clinical/regulatory courses.
• Evaluate and advise clinical/regulatory students.
• Support efforts to attain and maintain appropriate accreditation for programs related to clinical and regulatory affairs.
• Engage in active scholarship and service.
• Perform other duties as determined by the department chair or dean.

Requirements

• Extensive experience in one or more of the following areas: clinical research, regulatory affairs, or quality assurance.
• Industry experience in the areas of drugs and biologics, cell and gene therapies, medical devices, and/or diagnostics is preferred.
• Experience with the FDA is required, while experience with non-US regulatory bodies is highly desirable.
• A minimum of 10 years of industry experience in clinical, regulatory and/or quality assurance.

Qualifications

• A graduate degree in a life science field is preferred.
• Demonstrated experience and expertise in regulatory standards for approval, manufacturing and/or use of parenteral regulated medical products.
• Experience working with (or within) one or more regulatory agencies.
• Excellent oral and written communication skills.
• Experience developing and mentoring current and potential industry talent.
• Strong organizational skills and ability to manage multiple simultaneous projects and tasks.
• Prior teaching experience is desirable.