Experience

Laboratorio Farmacologico Milanese SRL

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Regulatory Affairs Specialist

  • Jan 2018 - Present



Recipharm

• Sweden
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Specialist

  • Apr 2015 - Dec 2016



PH&T S.p.A

• Milano

• Regulatory Affairs

  • Feb 2015 - Mar 2015



LISAPHARMA

• ERBA

• Regulatory Affairs Specialist

  • Apr 2008 - Jan 2015

  Preparation of documentation for submission to Italian Medicinal Agency (|AIFA|) and |Ministry of Health| in compliance with current legislation to ensure efficient registration. Life-cycle management (|variations|, |marketing authorization renewal|, |labeling updates|, |artwork revision| and |approval|). Notification and updates of the labelling of |food supplements| in compliance with current legislation. Preparation of documentation of |Technical File| for |Medical Devices| (class I, IIa, IIb and III) for submission to the Notified Bodies (including the Istituto Superiore di Sanità) to obtain the |CE certification|. Preparation and updates of documentation of |Site Master File| of the manufacturing site, the parts related to the Regulatory aspect. Regulatory support in the pre-audit phase and during the audit of the manufacturing site by the Competent Authorities. In cooperation with the Quality Assurance department, management of the documentation for the |ISO 13485 certification| (Notified body: Certiquality) for the production and projecting of medical devives. Regulatory support to customers during the transfers of technology and production. Show less



Keryos S.p.A.

• Pharmaceutical Manufacturing

• Ricercatore Regulatory Affairs

  • 1998 - 2008

  From 1998 to 2005 in the |Molecular Biology Lab| I developed new modified microorganisms by the |molecular biology| technique suitable to produce recombinant proteins. From 2005 to 2008 I moved to the |Regulatory Affairs| department of the company. From 1998 to 2005 in the |Molecular Biology Lab| I developed new modified microorganisms by the |molecular biology| technique suitable to produce recombinant proteins. From 2005 to 2008 I moved to the |Regulatory Affairs| department of the company.



Pharmacia Upjohn

• Nerviano

• Ricercatore Senior in staff

  • May 1995 - 1998

  In the |Molecular Neurobiology| lab of the department of |Central Nervous System| I performed studies to test novel molecules for the treatment of several CNS disorders such as Stroke and Alzheimer disease. In the |Molecular Neurobiology| lab of the department of |Central Nervous System| I performed studies to test novel molecules for the treatment of several CNS disorders such as Stroke and Alzheimer disease.



Scuola Media Europea

• Abbiategrasso (MI)

• Science Teacher

  • Sep 1991 - Jun 1992

  Teacher in Science and Math in Secondary school Teacher in Science and Math in Secondary school