Yanming An Ph.D. RAC

o Provide technical guidance and direction to team members who review the product quality, manufacturing process and control, and pharmaceutical development information submitted in regulatory submissions, such IND, BLA, supplements. o Make regulatory decisions on submissions seeking concurrence for clinical studies or marketing approval of new drug/biologic products. o Act as Application Technical Lead (ATL) of CMC review team for BLA. o Maintain relevant documents of policies, procedures, and written instructions; provide recommendations to policy initiatives based on regulatory submission reviews. o Provide guidance and recommendations to industry representatives on scientific and regulatory issues during product development through formal FDA meetings. o Represent the Agency at professional/scientific conferences o Plan and organize the work of a team to complete a regulatory project; monitor and report on the status and progress of work, check on work in progress and review completed work.

o Conduct the review of product quality, manufacturing process and control, and pharmaceutical development information submitted in regulatory submissions. o Evaluate identification and characterization of drug substance's physical, chemical, biological and mechanical properties and their impact on the drug product. o Evaluate manufacturing processes and facilities used by foreign and domestic manufacturers of drug substances and/or products. o Participate in the facility inspections related to the evaluation of manufacturing processes and controls and in support of pre-approval and cGMP inspections. o Provide regulatory recommendations to the team and the management based on evaluations. o Interact with industry representatives on regulatory issues.

o Participate in the review and analysis of chemical processes and/or formulation involved in the manufacturing of vaccines. o Analyze and evaluate written scientific and technical data to review drug applications and their amendments/supplements. o Determine the adequacy of testing for materials, manufacturing processes, and drug products. o Identify problems and deficiencies within drug manufacturing processes. o Conduct research on the medical products; draft research manuscripts and peer review for scientific publications; present papers at professional scientific meetings

o Conduct cancer proteomics studies using mass spectrometry, liquid chromatography.