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Remote adjunct position- Regulatory Affairs for Cell and Gene Therapy 2
The Drexel University College of Medicine’s Department of Microbiology and Immunology and the Institute for Molecular Medicine and Infectious Disease is searching for an Adjunct to create and teach the new course MIIM 574S Regulatory Affairs for Cell and Gene Therapy 2. This 3-credit course explores cell and gene regulatory affairs from product licensure and into post-approval life cycle management, post-approval change reporting categories, accelerated approval mechanisms, managing agency inspections, and international market requirements for cell and gene regulatory affairs. Specific focus will be on developing skills in formulating regulatory strategies from a scientific, risk-based approach by exploring hypothetical scenarios hypothetical scenarios a regulatory affairs professional
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