Massimo Marcozzi

Experience

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  Babel Radio Show-RUC

  Feb 2017 - Jun 2017

  Radio/TV presenter in Babel Radio Show-RUC, Coimbra (Portugal)

  Volunteering work experience as Radio speaker for “RUC radio station of Coimbra”, developed in English and Portuguese, discussing Erasmus study issues.

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  Thermo Fisher Scientific

  Jun 2018 - May 2019

  PDS Manufacturing Scientist Intern

  ● Increased production flow of sterile and freeze-dried liquid injectable pharmaceutical forms through the rapid and correct choice of the filter unit to carry out the sterilizing filtration, meeting the GMP requirements and the defined production objectives. In order to speed up the choice of the filtering unit, I carried out laboratory tests in NON GMP conditions: Vmax filterability studies, Bubble Point (Integrity test), test of the dead volume of recovery of the solution from a normal production filtration line to expand the yield of the filtered product.● Supporting the Supervisor during the production of GMP clinical and commercial batches to ensure the adherence to GMP standards.● Correct management, cataloging and recording of Master Batch Record files to optimize production efficiency and ensure the traceability of related data. Consequent constant alignment with the PDS department and multitasking work to reduce the writing time of MBR files.● Constant direct communication with material suppliers, collaborators and customers for greater team working between the parties. Show less

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  Lucangeli private pharmacy in Teramo

  Jan 2019 - Jul 2019

  Apprentice

  ● Technical administrative management of the pharmacy relating to the organization and implementation of the pharmaceutical service based on current legislation related to regular filing of the documentation.● Warehouse organization to increase the sales flow of requested products.● Information and health education for the population with sales assistance to customers carried out under the supervision of a qualified pharmacist to ensure rapid and correct supply of medicines.

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  Rural Pharmacy and Pharmaceutical Dispensary of Dr. Calafiore and Dr. Crescenzi

  Jul 2020 - Oct 2020

  Pharmacist

  ● Total technical administrative management of the pharmacy relating to the organization and implementation of the pharmaceutical service according to current legislation: management of the DPC, drugs, warehouse for supply and return orders, cash register closing.● Sale of drugs and electro-medical machinery for self-medication over the counter● Patient primary health care services such as blood pressure measurement● Excellent interpersonal skills expressed in customer care to ensure quality and safety in the services provided and provide acorrect scientific education of the population● Collaboration with scientific representatives of multiple pharmaceutical companies Show less

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  Pharmacy "Della Piazza"

  Oct 2020 - Jan 2021

  Collaborating Pharmacist

  ● Administrative technical management of the pharmacy relating to the organization and implementation of the pharmaceutical service based on current legislation: management of DPC, drugs, warehouse for supply orders and returns.● Over the counter sale of drugs, organic and celiac food, items for children and babies, cosmetics and self-medication electro-medical machinery.● Patient primary health care services such as blood pressure measurement.● Excellent interpersonal skills expressed in customer assistance to guarantee quality and safety in the services provided and provide one correct scientific education of the population.● Collaboration with scientific representatives of multiple pharmaceutical companies. Show less

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  Sanofi

  Feb 2021 - now

  ● Managing of Technology Transfer (Transfer-in/Transfer-out) documents under Regulatory point of view: VRC, Protocols, Reports, Regulatory Strategy, updating and/or editing new dossier (preparation core package for dispatch). Close collaboration with Global Regulatory Affairs functions, Local Drug Regulatory Affairs, Donor/receiving site, external stakeholders internal functions of the plant (QA, QC Lab., IT, SC, Packaging and Warehouse).● Registration and Lifecycle management of dossier products (DS and DP part, Module M1, M2, M3) by updating the CMC documentation for EU and Extra-EU markets (including Japan and EAEU Eurasian).● Preparation of regulatory package according to EU and non-EU guidelines based on the validated regulatory strategy and consequent submission of the variation to the Regulatory agencies (AIFA, EMA, FDA and non-EU functions).● Managing of pre-and post approval activities: MA Transfer, MA renewals, EU and Extra-EU HAs requests.● Regulatory Compliance of site products (solid oral pharmaceutical forms) with relative Gap Analysis carried out in collaboration with internal functions of the plant.● Managing of the changes to the product information under Regulatory point of view.● Preparation of documentation package for site changes (major and minors) to be submitted to AIFA.● Review of quality and safety questionnaires on raw materials, APIs and excipients with distributors/manufacturers.● Team GMP Audit.● Control of site internal technical documentation for Site Master File updates. Show less ● Managing of Technology Transfer (Transfer-in/Transfer-out) documents under Regulatory point of view: VRC, Protocols, Reports, Regulatory Strategy, updating and/or editing new dossier (preparation core package for dispatch). Close collaboration with Global Regulatory Affairs functions, Local Drug Regulatory Affairs, Donor/receiving site, external stakeholders.● Registration and Lifecycle management of dossier products (DS and DP part, Module M1, M2, M3) by updating the CMC documentation for EU and Extra-EU markets (including Japan and EAEU Eurasian).● Preparation of regulatory package according to EU and non-EU guidelines based on the validated regulatory strategy and consequent submission of the variation to the Regulatory agencies (AIFA, EMA, FDA and non-EU functions).● Managing of pre-and post approval activities: MA Transfer (Transfer-in/Transfer-out), MA renewals, EU and Extra-EU HAs requests.● Collaboration with Global Regulatory Affairs functions, Country Affiliates and internal functions of the plant (Quality Assurance, Quality Control Lab., Industrial Technology, Production, Supply Chain, Packaging and Warehouse) to define the Regulatory Strategy and submission timeline to respect the projects date.● Regulatory Compliance of site products (solid oral pharmaceutical forms) with relative Gap Analysis carried out in collaboration with internal functions of the plant.● Managing of the changes to the product information under Regulatory point of view.● Preparation of documentation package for site changes (major and minors) to be submitted to AIFA.● Revision of artworks: collaboration with Supply Chain and Pharmacovigilance Departments.● Review of quality and safety questionnaires on raw materials, APIs and excipients with distributors/manufacturers.● Team GMP Audit● Control of site internal technical documentation for Site Master File updates. Show less

  • Regulatory Affairs Specialist

    Feb 2022 - now

  • Stagiaire Regulatory Compliance

    Feb 2021 - Feb 2022