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Regulatory Affairs Specialist
Stanford University
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Regulatory Affairs Specialist
Stanford University
![]() Regulatory Affairs Specialist Stanford University Grade: J FTE: 100% The Laboratory for Cell and Gene Medicine (LCGM) is offering an exciting new professional opportunity: Regulatory Affairs Specialist (ASA2); a role specifically created for its Good Manufacturing Practice (cGMP) facility. Stanford Health Care (SHC), Lucile Packard Children's Hospital (LPCH), and the Stanford University School of Medicine (SOM) are jointly developing innovative cell and gene-based therapies for the treatment of disease and the promotion of health in pediatric and adult patients. The LCGM offers a team-based approach to providing process development and manufacturing services to Stanford Medicine investigators to develop and implement leading-edge cell and gene-based therapies for Phase I and II clinical trials. The Regulatory Affairs Specialist reports to the Associate Director of Regulatory Affairs and plays a critical role in developing and managing Investigational New Drug (IND) submissions to the IND and in creating policies and procedures to ensure compliance with US Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs): (21 CFR Parts 210, 211); Human Cells, Tissues, and Cellular and Tissue-based Products (21 CFR Part 1271); and Biologics (21 CFR 600) regulations. Learn more about our team here: https://med.stanford.edu/lcgm.html. Duties include:
* Other duties may also be assigned DESIRED QUALIFICATIONS:
EDUCATION & EXPERIENCE (REQUIRED):
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
CERTIFICATIONS & LICENSES: None PHYSICAL REQUIREMENTS*:
* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. Additional Information Job: Location: School of Medicine, Stanford, California, United States Schedule: Classification Level: To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Copyright 2017 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency jeid-6f076fee4a6fba42a427a9b212afb150
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Internal Number: 2024783
About Stanford University
Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.
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