Regulatory Affairs Specialist

Piper Clinical Solutions is seeking a motivated Regulatory Affairs Specialist in Bethesda, MD to support an established research firm supporting both commercial and government clients with ongoing clinical research trials.

Responsibilities for the Regulatory Affairs Specialist:

  • Prepare scientific and regulatory documents such as study protocols, investigator brochures, informed consent forms, annual reports, IND applications, IDE applications, and summary reports
  • Regulatory correspondence with PI’s and on-site monitors to communicate and educate involved parties on new protocols, amendments, and continual review updates
  • Prepare investigator/pharmaceutical company meeting minutes
  • Analyze preclinical/clinical research data, perform literature searches and extract information to support regulatory documents and prepare reports on findings
  • Maintain TMF related to ongoing studies and all regulatory documentation
  • Update, review, and maintain electronic databases for clinical trials

Requirements for the Regulatory Affairs Specialist: 

  • 3+ years of experience managing and submitting regulatory documentation for clinical trials (IRB/GCP/FDA)
  • Advanced knowledge of medical terminology
  • Working knowledge of database management programs, analytical tools, and CTMS
  • Ph.D. in science-related field preferred, Master’s Degree accepted

Compensation for the Regulatory Affairs Specialist:

  • Salary: based on years of relevant experience
  • Benefits: Health, Dental, & Vision insurance and 401K

Keywords:

Good Clinical Practice, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf, trial master file, standard operating procedures, protocols, adherence, sop