Clinical and Regulatory Affairs Strategy

  • Preparation of clinical and regulatory affairs strategy documents including study protocols, Investigators’ Brochure,  FDA meeting packages (e.g., pre-IND, EOP2), INDs and IND updates, and European CTAs
  • Prepare for and participate in meetings with regulatory agencies (US & EU)
  • Target product profile (TPP) preparation and updating
  • Generate product development plans (PDP)
  • KOL identification, selection and management, and organize KOL advisory board meetings
  • Prepare an overall project regulatory strategy based on region-specific regulatory guidances and guidelines
  • Review and analyze biotechnology company portfolio/assets and intellectual property in order to prioritize and allocate resources for development based on PTS