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Job Req ID:  15204

Regulatory Specialist II

The Department of Oncology is seeking a Clinical Research Regulatory Specialist II that will serve as a central resource for faculty conducting clinical research at Johns Hopkins University and across multiple clinical trial sites. Working closely with the Sponsor-Investigator and IND Specialist, this position will assist in the submission of investigator initiated trials to the appropriate regulatory agencies for review, such as the Food and Drug Administration (FDA) and Recombinant DNA Advisory Committee (RAC). In addition, this position will assist in the ongoing maintenance of Sponsor-Investigator held INDs. This includes, but is not limited to protocol amendments, Investigator Brochure amendments, annual reports, IND safety reports, Chemistry, Manufacturing, and Controls (CMC) updates, and oversight of investigational drug supply. 



  • Provide assistance in the submission of Investigational New Drug Applications (IND)
  • Provide regulatory guidance to IND sponsors, clinical investigators, and clinical staff for investigator initiated clinical trials
  • Provide assistance with IND management and submissions
  • Coordinate and review documentation for amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs
  • Compile and maintain IND Sponsor regulatory files (digital and hard-copy) throughout the lifecycle of sponsorship by ensuring that incoming and historical documents are organized and filed appropriately
  • Review clinical trial databases to assess clinical data quality and accuracy
  • Monitor investigational drug supply



Bachelor’s degree in health sciences, biological sciences, or related field and three years clinical trial regulatory experience at an academic, government, or pharmaceutical industry environment. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.


JHU Equivalency Formula:  18 graduate degree credits may substitute for one year of experience.  



Advanced degree in regulatory, health sciences, biological sciences, or related field desired.






Classified Title: Regulatory Specialist II 
Role/Level/Range: ACRP/03/MB
Salary:  $38,536 - $52,989
Status:  Full-Time
Department name: 10002940-Cancer Immunology/GI Clinical Research 

Work Schedule/Hours: M-F 8:30 - 5 
Location: 04-MD:School of Medicine Campus 
Personnel area: School of Medicine




The successful candidate(s) for this position will be subject to a pre-employment background check.


If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.


The following additional provisions may apply depending on which campus you will work.  Your recruiter will advise accordingly.


During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.


The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.


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