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Manufacturing / Mechanical
Hannah Lee

Hannah Lee

Senior Manager for Global Regulatory Affairs


About Hannah Lee:

  • Specific products – Adalimumab, Infliximab, Rituximab, Trastuzumab, New formulation of Infliximab (SubQ), Anti-SAR-Covid 19 treatment products (Regdanvimab), Ustekinumab
  • Monoclonal Antibody Treatments for Biosimilar products and a new drug of COVID 19
  • To build the regulatory dossiers and Communicate key strategic issues to/from global countries (Pharm-emerging markets) particularly in CA, AU, NZ, Middle East (Saudi Arabia, UAE, Kuwait, Bahrain, Oman, Qatar), Jordan, Iraq, and North Africa (Egypt, Algeria, Morocco)
  • Proactively managing submission of plans aspects of commercial and/or clinical programs; timely preparation and submissions of global regulatory filings including, clinical trial and marketing applications, post-approval variations and license maintenance activities
  • Researching and interpreting global CMC regulations and provide regulatory guidance to Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization.
  • Managing interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations and other submissions which present CMC information.
  • Country-specified CMC issues in Biologics– Setting up Temperature cycling stability study, Physiochemical Biological comparability(PCBC) studies and protocol. 
  • Oversee the management/maintenance of approved product licenses including updates of the administrative, nonclinical, and clinical portions of MAs (sites additions, CMC variations and labeling changes) and any required annual reports/requirements in the region.
  • Oversee the planning and preparation of complex submissions such as regular marketing applications (MAs), Emergency Use authorization (EUA) Pathway–UAE & Brazil, Provisional determination, Provisional pathway (AU), Abbreviation pathway (NZ) Priority Review (Saudi Arabia), and rolling review pathways to expedite regulatory approval in AUZ, CA, Brail, and MENA. 
  • Supports countries on activities such as on-site inspection, and audits
  • Knowledge and understanding of Detailed Description of Pharmacovigilance and PSUR and PBRER
  • Act as a global contact and/or lead for a specific customer. 
  • Lead major, global cross-functional initiatives, accountable for success. Continually looks for process improvements (Pfizer-AU, NZ, CA, HIKMA Pharmaceuticals, and other big pharma companies) 


Global Regulatory Affairs 


Cal Poly Univ Pomona

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