Mr_HeMr. He, MSc.

Project Management Manager

Mr. He obtained his Master of Science (MS) degree in Biotechnology and further received his certifications in Good Manufacturing Practices (cGMP) and in Advanced Regulatory Compliance Training at Georgetown University Medical Center. Mr. He started his career in regulatory affairs in 2020. As a highly motivated project management staff, Mr. He provides efficient project management assistance to project execution and cross-functional teams, working flexibly in countries across the globe. Mr. He contributes to eCTD submission and publishing, identification of submission risks, and opportunities, whilst assisting end-to-end delivery of regulatory projects.

In addition, Mr. He spent more than 3 years in molecular biology research and published 4 papers. Mr. He also worked as a research assistant at in two cancer-related projects.

Regulatory Project Management Expertise:

  • Q-Submission
  • 510K Application
  • Original IND
  • FDA meetings (INTERACT, pre-IND, and Type-C)
  • DSUR
  • Regulatory Intelligence
  • Submission Planning
  • Document Management
  • Formatting and Publishing
  • E-Submission
  • Submission Tracking