The primary responsibility of the Regulatory Affairs Senior Specialist is to serve as the regulatory lead for university held INDs, IDEs, and foreign CTAs. In this role, he/she will provide regulatory leadership, author of FDA submissions, contribute to and review core documents, liaise with the FDA and regulatory authorities, provide project management to sponsor teams and opine on regulatory strategy. In addition, he/she will provide day-to-day regulatory support and contribute to the development of operational processes, that will ensure adherence to government and institutional policies and provide guidance to current and potential Sponsors in Perelman School of Medicine (PSOM). This position will support potential IND/IDE/CTA Sponsors in offering guidance with FDA and international regulatory authority applications and amendments, processing IND/IDE/CTA exemption requests and will aid with the development and submission of related documents (consent forms, safety monitoring plans, investigator brochures, safety reporting etc). * Project Management * Provide regulatory support and guidance to Sponsors and Investigators * Write and edit Sponsor support tools and SOPs * Author and coordinate regulatory submissions and applications * Review IND/IDE/CTA exemption requests * Conduct Sponsor Training and Workshop training
Internal Number: 31323
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.