Manager – Research Regulatory

Detailed Description: 

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
Qualifications: Experience: 

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.

How to Apply: 
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