Experience

Sintetica

• Switzerland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• • Jan 2023 - Present

  Coordination of CMC activities for global markets, of internal and external resources. Actively writing of US ANDA and NDA dossiers as well of EU and ROW submission of injectables products

• • Dec 2020 - Feb 2023

  Autonomously authoring of CMC modules of WW registrations (US, EU, RoW) of drug products.Handling of DL responses from authorities and coordination of external consultants.Gap analysis / Risk Assessment for WW changes.Support to R&D people for new developments and variations.Evaluation of RIM systems (including DMS) for company implementation.



Zambon

• Pharmaceutical Manufacturing
• 700 & Above Employee

• • Sep 2017 - Nov 2020

  Autonomously authoring of CMC modules of WW registrations (EU, RoW) of Established Zambon drug products (oral, injectable, inhalation and topical products).Management of external consultants for new submission and/or variations and respective DL responses handling.Gap analysis / Risk Assessment for WW changes.Support to plant functions for changes evaluation.Implementation of Veeva Vault RIMS (registration, submission and submission archive modules). Management and Training of end users. Show less

• • Jan 2017 - Aug 2017

  - Development of generic dossier in CTD and eCTD format for European and FDA submission.- Reviewing of various regulatory documents (protocols, reports, etc.) - writing of CMC sections of eCTD.- Management of ANDA submissions and activities related to the projects.



ZACH SYSTEM S.P.A.

• Italy
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Nov 2013 - Dec 2016

  - Development of generic dossier in CTD and eCTD format for European and FDA submission.- Reviewing of various regulatory documents (protocols, reports, etc.) - Managing European DCP Procedures and activities related to the projects.- Management of ANDA submissions and activities related to the projects.

• • Nov 2012 - Oct 2013

  - Writing and review of DMF, technical packages, DMF updates and amendments for submissions to Health Authorities and customer’s worldwide.- Managing US and Canadian DMFs (Annual/Biannual Report/Updates and Amendments)- Regulatory Compliance to guidelines.- Interface with Manufacturing, R&D, QA and/or Marketing to identify and resolve regulatory issues for new and current product lines.



Sintetica

• Switzerland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• RA - R&D Associate

  • Apr 2009 - Nov 2012

  - Formulation of injactables (generic, new chemical entities) - Development and Validation of analytical methods - Compilation, updating and maintenance of Drug Product Registration Dossiers in CTD, NeeS and eCTD. - Assembly and submission of regulatory applications (Marketing Authorisation including National Applications (Switzerland), MRP, DCP, Variations and Renewals) in the European Countries. - Communication with European Health Authorities and response to questions when required. - Regulatory Compliance to guidelines. - Monitor, interpret, and validate current and changing regulatory legislation and advise appropriately. - Regularly liaised with QA, QC, production and external project colleagues, providing regulatory advices, information and background files on products. - Pharmacovigilance activities in EU and CH - Readability Testing of EU Package Leaflets Show less



Packaging Imolese

• Imola - Italy

• Quality Manager

  • Sep 2008 - Jan 2009

  Quality System Management SOPs drafting Internal training and auditing. Support to the R&D projects Quality System Management SOPs drafting Internal training and auditing. Support to the R&D projects



European Commission

• Belgium
• Government Administration
• 700 & Above Employee

• Stage at the Dept. of Chemical and Phisical Exposures (Chemical Release of Disperse Dyes in textiles

  • Feb 2008 - Aug 2008

  Research and Development of alergenic dyes with cromatographic techniques (HPLC e GC-MS): - Development of extraction methods of textiles dyes - Development and validation of an HPLC method for the identification and quantification of dyes. Research and Development of alergenic dyes with cromatographic techniques (HPLC e GC-MS): - Development of extraction methods of textiles dyes - Development and validation of an HPLC method for the identification and quantification of dyes.



Chemical Resolution

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QC Technician

  • Aug 2007 - Jan 2008

  Raw Material, Intermediates, Finished Product Analysis of APIs. Raw Material, Intermediates, Finished Product Analysis of APIs.



B&C Srl

• Forlì - Italy

• Laboratory Technician

  • Sep 2006 - Feb 2007

  Experimental Thesis: ‘Planning, Quality Characterization, Efficacy Evaluation of an Antiseptic Formulation’ Development of a topic antiseptic formulation Quality Control of cosmetics and supplements Experimental Thesis: ‘Planning, Quality Characterization, Efficacy Evaluation of an Antiseptic Formulation’ Development of a topic antiseptic formulation Quality Control of cosmetics and supplements