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)
