İlayda Kaya Email & Phone Number

-Prepared and managed registration submissions, renewals, and variation packages according to current Ministry of Health requirements (AU, EU, CA, CH, US, NZ & Nordic countries).-Prepared and supported dossier submissions to obtain marketing authorizations and kept related systems and databases updated in a timely manner.-Collaborated with cross-functional teams (R&D, QC, QA, and Manufacturing) to prepare dossiers and resolve regulatory issues, expedite product launches, and maintain regulatory compliance.-Conducted regulatory assessments of product changes, labeling, and manufacturing processes.-Prepared SmPC/PIL submissions.-Managed written correspondence before and after registration approval. Followed up on regulatory requirements in regulated markets.-Provided full regulatory support across the related line units based on the responsible portfolio.-Maintained a complete archive of all business communications and documents.

-Managed literature, patent, and pharmacopeia searches on the molecules designated for development.-Developed dissolution methods and investigated sink conditions.-Prepared in-vitro reports.-Managed analytical method verification, analytical method validation, and process validation studies according to pharmacopeia standards.-Prepared all analytical documents for dossier submission of new products.-Performed analytical tests on API, finished product, and stability samples. Results are documented according to GMP.

-Implemented GMP and GLP practices.-Observed in the pharmaceutical development laboratory and analytical development laboratory.

Bachelor'S Degree, İşletme

Bachelor'S Degree, Chemistry, 3.14/4 (Honor Student)

Activities and Societies: İU-C Kimya kulübü, KİMTOMühendislik Fakültesi