Roberta Cocomazzi
Regulatory Affairs Officer at Italfarmaco- Claim this Profile
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English Professional working proficiency
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Italian Native or bilingual proficiency
Topline Score
Bio
Credentials
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Food Supplements-technical aspects and legal framework
Life Science AcademyOct, 2021- Sep, 2024 -
GdL-SIARV Giovani
SIARV - Società Italiana Attività Regolatorie, Accesso, FarmacoVigilanzaJun, 2021- Sep, 2024 -
Associate Member
Farmaceutica YoungerDec, 2020- Sep, 2024 -
Abilitazione Farmacista
Università degli Studi 'Gabriele d'Annunzio' di ChietiJan, 2019- Sep, 2024 -
PEF 24 CFU
Università degli Studi 'Gabriele d'Annunzio' di ChietiJul, 2018- Sep, 2024 -
Stage di formazione azienda di distribuzione Guacci
GUACCI S.P.A.May, 2016- Sep, 2024 -
“La realtá occupazionale nel settore farmaceutico”
Università degli Studi 'Gabriele d'Annunzio' di ChietiApr, 2016- Sep, 2024 -
Upper Intermediate level
University College CorkAug, 2008- Sep, 2024 -
P.E.T. ESOL Examination
University of CambridgeJan, 2008- Sep, 2024
Experience
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Italfarmaco
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Spain
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs Officer
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Jun 2022 - Present
LCM Management of a portfolio of Medicinal Products and Food Supplements -Submission of NP variation and follow-up via AIFA Front End -Submission of DCP/MRP Variation and follow-up via CESP -National Phase of the Authorization Procedure - Sunset clause management -publishing on eXtedo/ Lorenz Validator/eCTD manager -ArtWorks evaluation -Promotional Material evaluation - regulatory strategy and evaluation of new project (launch on the market of new product) - e-Dossier and Pricing management/submission on AIFA FrontEND Show less
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ProductLife Group
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France
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Medical Writing & Regulatory Affairs Associate
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Jan 2022 - May 2022
-PSURs, DSURs, AddCo (Pharmacovigilance Writing) use of MedDRA - Literature research: PubMed, Mendeley, GoogleScholar - Drug Regulatory Compliance Tool for 300 MAs - DRAGON-
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Regulatory Affairs Associate
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Jun 2021 - May 2022
I am currently in charge with Italian and Swiss Pharmaceuticals Company. I am increasing my expertise on Swiss-regulation close to the European regulation on Pharmaceutical Product. In particular I am Insourcing in one of the top FIVE pharmaceutical company in the world: Management of wide projects-Vaccines project: Naas, FO, and variations -PI review with TVT and PI and SmPC management according with A109 Requirements -submission to Swissmedic portal in eDok and eCTD-Preparation of the package documents for submission M1 and M3 and all the annexes documents following the Swissmedic regulation.-Dossier management Show less
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Regulatory Affairs Officer
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Feb 2021 - May 2021
Support for the following activities: -Submissions with DCP, MRP, NP of generics medical products, response with the PrAR to the RMS and CMS -submission of variations -module 1, 2.3 and 3.2.S and 3.2.P of CTD and eCTD -management, request and revision of the following documents DMF, ASMF, CEP... -tabled values of CoAs, Stability data - Gap Analysis -management of the activities with suppliers and customers -submission to the NCA portal -pharmacovigilance assistant -quality assurance asssistant Show less
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Farmacista Libero Professionista
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Nov 2020 - Jan 2021
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Boots UK
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United Kingdom
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Retail
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700 & Above Employee
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Farmacista collaboratore
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Oct 2020 - Jan 2021
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Farmacista collaboratrice
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Mar 2019 - Sep 2020
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Education
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2019 - 2021
Università di Pavia
Master biennale di II livello in Discipline Regolatorie G.Benzi -
2020 - 2021
Madrelingua Corner - Ielts Bergamo Milano - corsi di inglese
C1- IELTS, Private English course -
2020 - 2021
Coaching
Private course one-to-one with the Career coach Lorenza Moscarella, Career coaching -
Università degli Studi 'Gabriele d'Annunzio' di Chieti
Doctor of Chemical and Pharmaceutical Technology - PharmD, LMCU in Chimica Tecnologia Farmaceutica
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