Associate Director, Regulatory

Job Description Summary

With the oversight of the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division. The Associate Director for Regulatory Affairs assists the Director in providing direction and strategic planning for clinical research regulatory operations including overseeing the activities of a Regulatory Office (or Regulatory Program)/reporting regulatory affairs staff, anticipating and planning for changes in the regulations governing clinical research, planning for the regulatory aspects of growth of department/division research activity, and liaising with regulatory groups across the department/division, University, and federal government.

Job Responsibilities

• Oversee portfolio of clinical research and regulatory operations
• Directly oversee, train and mentor reporting Regulatory Affairs staff
• Serve as primary point of authority on regulatory affairs matters
• Represent department with internal and external regulatory groups
• Oversee regulatory submissions to IRB and other committees
• Other duties as assigned

Qualifications

Bachelor's degree and 7-10 years relevant experience, or a combination of education and experience required. Master's degree preferred. ACRP and/or RAC certification required. Expert knowledge of GCP, and relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines required.