Manager - Research Regulatory

Employment Type

: Full-Time

Industry

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NYU School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on Facebook, Twitter and Instagram.

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.

Job Responsibilities:

  • 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

Minimum Qualifications:
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

Preferred Qualifications:
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.

Position Summary:
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.

Minimum Qualifications:
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

Preferred Qualifications:
Professional experience in FDA IND/IDE/regulatory role
Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS)


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