Current Job and Project Opportunities

Posting: #FDAAA 17-024
Job/Opportunity: Manager-Research Regulatory
Organization: NYU Langone Health

This position 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.

Responsibilities:

  • Support the development and coordination for the submission of Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications
  • Facilitate communication with the relevant regulatory agencies as appropriate
  • Assist investigators with determinations of applicability of IND and IDE requirements, including conducting the necessary regulatory and scientific literature searches
  • Collaborate with Sponsor-Investigators to maintain and manage their IND/IDEs
  • Provide guidance to investigators on the use of institutional templates for drug and device protocols and IND/IDE applications
  • Support the implementation and maintenance of the institutional IND/IDE Sponsor/Sponsor-Investigator standard operating procedures (SOPs)
  • Serve as an educator and lead training sessions to ensure regulatory compliance with regulatory requirements, federal guidance, and institutional policies and SOPs
  • Consult on the effort and budget required for regulatory activities in the submission of funding proposals
  • Maintain up-to-date knowledge on FDA and international regulatory requirements and current practice standards for clinical trials including regulatory submissions
  • Contribute 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
  • Oversee centralized clinicaltrials.gov registration and reporting process and staff

Qualifications:

  • To qualify you must have an advanced degree in a health-related field
  • 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 minimal direction

Please apply: http://jobs.nyulangone.org/job/7512646/manager-research-regulatory-new-york-ny/

Posting Date: 09/17