REGULATORY AFFAIRS SPC SR
Duties: 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
Qualifications: * A Bachelor's Degree and5-7years relevant experience in clinical regulatory environment, or combination of education and experience required. Masters degree in a science related field is a plus.
* IND/IDE/Clinical Application experience
* Knowledge and experience with FDA Clinical Trial regulations and guidance (GMP, GLP, GVP, and GCP)
* Demonstrated ability to work on projects independently
* Strong writing skills
Reference Number: 40-25113
Salary Grade: 028
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Special Requirements: Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Job Family: A-General/Professional Administrative