SR. REGULATORY AFFAIRS SPECIALIST
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).
Qualifications: * A Bachelor's degree and 5 years to 7 years of experience in a clinical research regulatory environment or equivalent combination of education and experience required. Master's degree in a science related field is a plus.
*Prior experience in clinical trials and experience implementing GCP, GMP, GLP, and GVP/Safety regulations is required.
*Regulatory Affairs Certification (RAC) preferred
* Experience and functional knowledge of FDA clinical trial regulations specifically IND and IDE regulations
* Demonstrated ability to work independently and drive processes
* Demonstrated ability to manage projects
* Excellent writing skills; experience in policy and SOP development
* Project management experience is essential.
* Ability to work with individuals from all levels within the organization
Reference Number: 40-28164
Salary Grade: 028
Employment Type: Exempt
Org: SM-DN-Office of Clinical Research
Job Family: A-General/Professional Administrative