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