Nasim Hakimiha

Iran Iran, Islamic Republic of

Regulatory Affairs Manager

Medical / Health Care / Pharmaceuticals

Registration dossier preparation, review and update, and submission Pharmaceutical Market Research Submission and review of pharmaceutical and plasma products at Iranian MOH Regulatory Affair- preparing drug master file in CTD format- familiar with regulaton of plasma and blood products.biologic products especially vaccine. Working experience / academic knowledge in CTD format of DMF for both locally made drugs and imported medicines prepare and present marketing business plan (strategy) per product on an annual basis Active in Contract manufacturing Specialties: Regulatory affairs- plasma & blood product- CTD prepration official expert in pharmacy and toxicology