Jiannan Geng

-Responsible for the NDA works of the Frontier’s main product-Albuvirtide (Aikening ®) in emerging countries (including ASEAN countries, Latin America, African countries, CIS countries). -Work together as a team member to collaborate with management and cross-functional colleagues (including nonclinical & clinical development, pharmacovigilance, research and development, CMC, commercial medical affairs, business development) on regulatory submissions, regulatory insight for assigned projects, and ensure the submission of NDA dossier to multiple countries. -Tracking, collecting, learning and summarize the IND/NDA registration regulation of various countries (including emerging countries, FDA and EMA), and provide strategies for registration plans to RA and R&D team. Familiar with the registration procedure and regulatory information of NPRA, TFAD, SAHPRA, ANVISA, EAEU, etc.

-Prepare outlines, summaries, status reports, and presentation materials for distribution and communication to Regulatory Affairs and other departments. -Timely/closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed. -Tracking, compiling and maintaining full regulatory applications including initial INDs and NDAs.

-Manage IND and BLA project deliverables and timelines in close cooperation with Project Teams. -Prepare or assist with the preparation of regulatory documents for submission to Regulatory Agencies, including writing, publishing, and correct placement in eCTD hierarchy. -Maintain Regulatory records, including archive of submissions and FDA correspondences files. -Assist with tracking the progress of clinical trials.

Physician Assistant -Complete Pre-admission histories and physicals, and consultations. Document findings, noting pertinent normal and abnormal findings. Perform electronic documentation of daily progress notes. -Order and interpret appropriate diagnostic and laboratory tests. Diagnose acute and chronic medical conditions. Formulate and implement treatment plan for acute illness. Document in the medical record. -Assess the patient for change in status and institute appropriate interventions. Initiate necessary emergency interventions to stabilize the patient. -Perform and participate in quality/performance improvement activities and clinical research.