Kadıköy, Istanbul, Türkiye
- Preparing, reviewing and coordinating local regulatory submissions (including initial,amendments, import license submissions and periodic reports) to MoH and EC in alignment with global submission strategy - Providing local regulatory strategy advice (MoH &/or EC) to internal clients - Updating RegView during the year to help company systems reflected current local requirements - May have contact with investigators for submission related activities - Key-contact at country level for either Ethical or Regulatory submission-related activities - Coordinating with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines - Ensuring alignment of submission process for sites and study are aligned to the critical path for site activation - Achieving the company's target cycle times for site - Preparing the regulatory compliance review packages once MoH approval receives for substantial/non-substantial amendments - Developing country specific Patient Information Sheet / Inform Consent Form documents
Working under contract with MSD
Working under contract with MSD
*Still maintaining the Pfizer's Phase 3 Hemophilia A projects at Ege University Children Hospital. *Also i have 2 more sponsors projects: Amgen (phase3 immune trombocytopenia) and Octopharma (phase3,congenital fibrinogen deficiency). *Phase 1 Study (Pfizer) *Therapeutic areas: Pediatric Hematology,Severe Hemophilia A, Immune Trombocytopenia (ITP)
Therapeutic area: Oncology and Pediatric Hematology