dr_yangDr. Yang

Project Management Manager

Dr. Yang is a Certified Pharmaceutical Regulatory Affairs & Quality Operations and Clinical Research (RAQC) professional. Dr. Yang has a Bachelor of Pharmacy and Ph. D. in Pharmaceutical Sciences with more than 7 years’ of experience with regulatory affairs, regulatory operation, project management, and other relevant regulations and guidelines in the pharmaceutical industry with a strong emphasis and practice on verbal/written communication, GMP, regulatory requirements, protocols/SOPs and business operation strategies.

Regulatory Project Management Expertise:

  • Strong interpersonal skills with project management in an international collaborative team environment
  • Pharm R&D, GMP scale up and technology transfer
  • Drug Development, SOPs, preparing systematic pre-clinical evaluation documents
  • Highly self-motivated, dependable, and productive with strong analytical, problem- solving, prioritization and multitasking abilities
  • Original IND
  • DSUR
  • Regulatory Intelligence
  • Submission Planning
  • Document Management
  • Formatting and Publishing
  • E-Submission
  • Submission Tracking