Experience

Alvogen Pharma d.o.o.

• Regulatory Affairs Specialist

  • May 2014 - Present

  Compilation and maintenance of regulatory documentation, databases and systems. Coordination of efforts associated with the preparation of regulatory documents or submissions. Communication with regulatory authorities regarding pre-submission strategies, potential regulatory pathways and follow-up of submissions under review. Compilation and maintenance of regulatory documentation, databases and systems. Coordination of efforts associated with the preparation of regulatory documents or submissions. Communication with regulatory authorities regarding pre-submission strategies, potential regulatory pathways and follow-up of submissions under review.



Polifarm

• Serbia
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Jan 2008 - Apr 2014

  EN: My main responsibilities include: - conducting regulatory activities necessary for the timely preparation and submission of the registration and renewal dossiers, variation files, dossiers for reimbursement drug list etc. - preparing SmPCs, PILs/PIs, mock-ups; I am responsible for documentation and dossiers for human and for veterinary medicines, as well as for documentation for food supplements. ........................................................................................................ ES: Mis principales responsabilidades incluyen: - actividades necesarias para la preparación y procesamiento del registro tecnico, variaciones y el manejo de procedimientos para la Lista de reembolso. - preparación de fichas tecnicas, prospectos y los etiquetados. Ejerzo de responsable en aspectos como la documentación y dossieres tanto de medicamentos de uso humano como de uso veterinario, así como de complementos alimenticios. Show less



SPARK (formerly known as Academic Training Organisation)

• Logistics Officer

  • Jul 2006 - Jul 2007

  Organizing all the course logistics and communication for the courses under my duty. Organizing all the course logistics and communication for the courses under my duty.