Years of experience: 8

✔️ ITBusiness OwnerSolution Integrator🧨 Consulting🧮 EducationProject Manager

Trust Score

Exceptionally trusted; proven professional excellence.

80%
Donika's Career Path
Regulatory Affairs Project ManagerApr. 2024 -
Present
VDATARegulatory Affairs Project Manager
Milan, Lombardy, ItalyRegulatory Affairs and Compliance Manager
Regulatory Affairs and Information SpecialistNov. 2018 -
Dec. 2024
IBSA GroupRegulatory Affairs and Information Specialist
SwitzerlandIDMP Implementation Project Lead. Advanced Knowledge of processes and regulatory information managment (Veeva RIM suite System). Advanced knowledge of xEVMPD. Advanced knowledge of Drug Track database (Lorenz). Advance knowledge of eSubmissions (Veeva Pubblishing and eCTD Manager). SPOR User Management, Local HA tools as MHRA, SwissMedic ect.
Regulatory Affairs SpecialistDec. 2017 -
Nov. 2018
IBSA ItalyRegulatory Affairs Specialist
Lodi Area, Italy• Managed EudraVigilance data entry and updates for products via xEVMPD, ensuring regulatory compliance. • Utilized advanced knowledge of Lorenz drug track regulatory database for data enrichment and entry. • Collaborated with cross-functional teams to streamline regulatory processes and improve efficiency.

Donika's Posts

  • Regulatory Affairs Information and Project Management

  • Ingoing

No responses yet
0