Global Regulatory Affairs Fellowship

The one-year Global Pharmaceutical Sciences (GPS) Fellowship provides hands-on experience constructing global regulatory submission documents from the initial stages of document preparation to final submission. The fellow is a key member of the core team and shares responsibility for facilitating timely submission and publishing of documents to regulatory agencies around the globe. In addition, the fellow will have opportunities to manage several projects inside and outside of GPS as part of a comprehensive training program.

 Objectives of the Global Pharmaceutical Sciences Fellow

  • Assemble and manage regulatory documents in electronic Common Technical Documents (eCTD) format that meet regulatory standards
  • Interact with Global Regulatory Affairs, Clinical Development, Project Management, Clinical Manufacturing, Method Development, Process Development, Analytical Testing, Research and Development, Drug Safety, Toxicology, Clinical Pharmacokinetics, Labeling, Quality Assurance, Publishing and Marketing to discuss issues specific to Pharmaceutical Sciences, and apply the information acquired
  • Review and discuss analytical method development, validation and implementation with chemistry, manufacturing and controls team leaders and analytical scientists

Application Requirements

  • PharmD, PhD or DRSc from an accredited university or equivalent
  • MS in regulatory science, pharmacy industry-track courses and/or industry internship is desirable
  • Good oral and written communication skills, ethics, professionalism and an interest in the biopharmaceutical industry

Contact Us

For additional information or to apply for the fellowship, please contact:

William C. Gong, PharmD, FASHP, FCSHP
Director, Residency and Fellowship Programs
Associate Professor of Clinical Pharmacy
University of Southern California
School of Pharmacy
1985 Zonal Avenue
Los Angeles, California 90089-9121
Telephone: (323) 442-2625