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Position Summary: We have an exciting opportunity to join our team as a Mgr-Research Regulatory.
In this role, the successful candidate Reporting to the Director of Research Regulatory Services in the Office of Science and Research (OSR), the Manager will provide regulatory support services to research faculty in the planning and conduct of clinical trials, including development of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications and in interactions with the FDA supporting the filing and ongoing management of these applications.
Oversee centralized clinicaltrials.gov registration and reporting process and staff
Contribute significantly to the development, implementation and ongoing evaluation of strategies and processes to improve and ensure that FDA-regulated research at the institution is conducted in accordance with all required regulations
Train and mentor other regulatory staff members
Maintain up-to-date knowledge on FDA and international regulatory requirements and current practice standards for clinical trials including regulatory submissions
Consult on the effort and budget required for regulatory activities in the submission of funding proposals
Serve as an educator and lead individualized/group training sessions to ensure regulatory compliance with regulatory requirements, federal guidance, and institutional policies and SOPs
Support the implementation and maintenance of the institutional IND/IDE Sponsor/Sponsor-Investigator standard operating procedures (SOPs)
Provide guidance to investigators on the use of institutional templates for drug and device protocols and IND/IDE applications
Collaborate with Sponsor-Investigators and their research teams to maintain and manage their IND/IDEs
Assist investigators and research teams with determinations of applicability of IND and IDE requirements, including conducting the necessary regulatory and scientific literature searches
Facilitate communication with the relevant regulatory agencies as appropriate; and if requested facilitating FDA interface for investigators
Support the development and coordination for the submission of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications
To qualify you must have a Advanced degree in a health-related field (clinical research is preferred)
5 years of regulatory or relevant drug/device industry experience required
Strong working knowledge of FDA regulations and Good Clinical Practices (GCP), and experience in the interpretation of regulations and guidelines
Prior involvement in the guidance and preparation of major regulatory submissions
Ability to work both independently with minimal direction and within project teams, committees, etc. to attain goals
Professional experience in FDA IND/IDE/regulatory role
Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS)
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you’ll feel good about devoting your time and your talents.
NYU School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU School of Medicine’s EEO policies, please click here. Please click here to view the Federal “EEO is the law” poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.
Internal Number: 1058767_RR00032434
About NYU School of Medicine
NYU Langone Health is a world-class, patient-centered, integrated academic medical center, known for its excellence in clinical care, research, and education. Included in the 200+ locations throughout the New York area are five inpatient locations: Tisch Hospital, its flagship acute-care facility; Rusk Rehabilitation, ranked as one of the top 10 rehabilitation programs in the country; NYU Langone Orthopedic Hospital, a dedicated inpatient orthopedic hospital with all musculoskeletal specialties ranked top 10 in the country; Hassenfeld Children's Hospital at NYU Langone, a comprehensive pediatric hospital supporting a full array of children's health services; and NYU Langone Hospital—Brooklyn, a full-service teaching hospital and level 1 trauma center located in Sunset Park, Brooklyn. Also part of NYU Langone Health is the Laura and Isaac Perlmutter Cancer Center, a National Cancer Institute–designated cancer center, and NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history.