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Elena Monaco Email & Phone Number
Regulatory Affairs Specialist
at
Alfasigma
LinkedIn matched
✓ Verified Jun 2026
3 data sources
Profile completeness 86%
Current company
Role
Regulatory Affairs Specialist
Location
Rome, Latium, Italy
Company size
Who is Elena Monaco? Overview
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Quick answer
Elena Monaco is listed as Regulatory Affairs Specialist at Alfasigma, a company with 2524 employees, based in Rome, Latium, Italy. AeroLeads shows a matched LinkedIn profile for Elena Monaco.
Elena Monaco previously worked as Regulatory Affairs Junior Specialist at Alfasigma and Regulatory Affairs Italy - Pharma products at Alfasigma. Elena Monaco holds Corso Di Master Universitario Di 2° Livello-Cmu2, Sviluppo Preclinico E Clinico Del Farmaco: Aspetti Tecnico Scientifici Regolatori Ed Etici, 29/30 from Università Cattolica Del Sacro Cuore.
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Alfasigma
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Profile bio
About Elena Monaco
Passionate about regulatory compliance and pharmaceutical development, with a background in both academia and industry. Currently serving as a Regulatory Affairs Specialist at Alfasigma, I specialize in ensuring compliance with EU and Italian regulations for pharmaceutical products. Key responsibilities include formulating regulatory strategies, preparing documentation in CTD and eCTD formats, and managing regulatory procedures to support product lifecycle management.Prior to this role, I honed my research skills during a Master Thesis Trainee position at the National Institute of Health (ISS). Here, I investigated the toxic effects of emerging hormonal therapies using rat models, focusing on applications in gender affirmation treatments. This experience equipped me with a comprehensive understanding of rodent handling, experimentation, and ethical considerations in animal research.My academic journey includes a Master's degree in Pharmaceutical Biotechnology from Sapienza Università di Roma, where I graduated with top honors. Currently pursuing a second-level Master's degree in Preclinical and Clinical Drug Development at Università Cattolica del Sacro Cuore, I'm expanding my expertise in drug discovery, clinical trials, regulatory affairs, and pharmacoeconomics.Driven by a commitment to excellence and compliance, I am dedicated to contributing to the advancement of pharmaceutical research and development, with a focus on ensuring safe and effective therapies for patients worldwide.
Current workplace
Elena Monaco's current company
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Alfasigma
6 roles
Elena Monaco work experience
A career timeline built from the work history available for this profile.
Regulatory Affairs Junior Specialist
Current- sottomissioni e monitoraggio delle pratiche regolatorie mediante i principali portali;
- attività regolatorie relative al ciclo di vita dei medicinali (trasferimento titolarità, registrazioni, variazioni e rinnovi delle AlC per procedure Nazionali, di Mutuo Riconoscimento, Decentrate e Centralizzate in.
- allestire documenti amministrativi e redigere/revisionare documentazione tecnica (CTD- e-CTD) per medicinali nuovi e/o già parte del listino;
- interfacciarsi con le Autorità competenti: AIFAMinistero della Salute;
- supportare la Direzione nel mantenimento del Sistema di Gestione Qualità e di Farmacovigilanza in conformità alla normativa vigente, assicurando che l'Azienda operi nel rispetto di tutte le normative in materia.
- monitorare la legislazione vigente sui Farmaci,Dispositivi Medici e Nutraceutici;
Jun 2024 - Present
Regulatory Affairs Italy - Pharma Products
- Strategia normativa per la registrazione e la manutenzione dei prodotti farmaceutici in Italia, in conformità con le normative vigienti in UE e IT per i prodotti farmaceutici.
- Preparazionie della documentazione regolamentare in CTD ed eCTD, secondo le procedure aziendali.· Seguire e garantire la gestione delle procedure normative per le modifiche necessarie a garantire la gestione del ciclo.
- Garantire il continuo aggiornamento dei materiali di confezionamento per l'intero ciclo di vita del prodotto, in seguito alle richieste dei dipartimenti aziendali coinvolti e su richiesta degli enti regolatori
- Assicurare l'aggiornamento delle banche dati regolamentari aziendali
- Mantenere i contatti con i reparti interni coinvolti nella preparazione della documentazione e conaziende partner nella gestione celie attività normative pertinenti.
- Assicurare l'archiviazione della documentazione regolamentare e garantire la relativa distribuzioneinterna ai dipartimenti coinvolti secondo procedure interne
Dec 2023 - Jun 2024
Master Thesis Trainee
As a master thesis intern at National Institute of Health (ISS), I conducted studies on the toxic effects of novel hormonal therapies in animal models, focusing on rat models for male to female gender affirmation treatment. I have acquired multiple skills in rodent handling, husbandry, and experimentation, as well as in legislation, ethics, and welfare of.
Oct 2022 - Oct 2023
Student Tutor
Tutor studenti didattico-amministrativo per il dipartimento di scienze biologiche
Mar 2023 - Sep 2023
Student Tutor
Studente tutor didattico amministrativo per il dipartimento di medicina molecolare
Apr 2021 - Oct 2021
Team & coworkers
Colleagues at Alfasigma
Other employees you can reach at alfasigma.com. View company contacts for 2524 employees →
NS
Nicoletta Stefanini
Colleague at AlfasigmaRome, Latium, Italy, Italy
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AD
Annalisa De Fusco
Colleague at AlfasigmaItaly, Italy
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MM
Massimo Mazzarella
Colleague at AlfasigmaNaples, Campania, Italy, Italy
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MN
Massimo Nava
Colleague at AlfasigmaItaly, Italy
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EM
Emmérancienne M.
Colleague at AlfasigmaGreater Paris Metropolitan Region, France
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DI
Domenico Intorre
Colleague at AlfasigmaItaly, Italy
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FM
Francesco Mancini
Colleague at AlfasigmaAprilia, Latium, Italy, Italy
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GC
Giuseppe Costantino
Colleague at AlfasigmaVilla San Giovanni, Calabria, Italy, Italy
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LG
Laura Galantucci
Colleague at AlfasigmaBologna, Emilia-Romagna, Italy, Italy
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ST
Sandro Tiberi
Colleague at AlfasigmaPescara, Abruzzi, Italy, Italy
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Nicoletta Stefanini
Colleague at AlfasigmaRome, Latium, Italy, Italy
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AD
Annalisa De Fusco
Colleague at AlfasigmaItaly, Italy
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MM
Massimo Mazzarella
Colleague at AlfasigmaNaples, Campania, Italy, Italy
View →
MN
Massimo Nava
Colleague at AlfasigmaItaly, Italy
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EM
Emmérancienne M.
Colleague at AlfasigmaGreater Paris Metropolitan Region, France
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DI
Domenico Intorre
Colleague at AlfasigmaItaly, Italy
View →
FM
Francesco Mancini
Colleague at AlfasigmaAprilia, Latium, Italy, Italy
View →
GC
Giuseppe Costantino
Colleague at AlfasigmaVilla San Giovanni, Calabria, Italy, Italy
View →
LG
Laura Galantucci
Colleague at AlfasigmaBologna, Emilia-Romagna, Italy, Italy
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ST
Sandro Tiberi
Colleague at AlfasigmaPescara, Abruzzi, Italy, Italy
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3 education records
Elena Monaco education
Corso Di Master Universitario Di 2° Livello-Cmu2, Sviluppo Preclinico E Clinico Del Farmaco: Aspetti Tecnico Scientifici Regolatori Ed Etici, 29/30
Laurea Magistrale, Biotecnologie Farmaceutiche, 110/110 Con Lode
Bachelor'S Degree, Biotechnology
FAQ
Frequently asked questions about Elena Monaco
Quick answers generated from the profile data available on this page.
What company does Elena Monaco work for?
Elena Monaco works for Alfasigma.
What is Elena Monaco's role at Alfasigma?
Elena Monaco is listed as Regulatory Affairs Specialist at Alfasigma.
Where is Elena Monaco based?
Elena Monaco is based in Rome, Latium, Italy while working with Alfasigma.
What companies has Elena Monaco worked for?
Elena Monaco has worked for Alfasigma, Istituto Superiore Di Sanità, and Sapienza Università Di Roma.
Who are Elena Monaco's colleagues at Alfasigma?
Elena Monaco's colleagues at Alfasigma include Nicoletta Stefanini, Annalisa De Fusco, Massimo Mazzarella, Massimo Nava, and Emmérancienne M..
How can I contact Elena Monaco?
You can use AeroLeads to view verified contact signals for Elena Monaco at Alfasigma, including work email, phone, and LinkedIn data when available.
What schools did Elena Monaco attend?
Elena Monaco holds Corso Di Master Universitario Di 2° Livello-Cmu2, Sviluppo Preclinico E Clinico Del Farmaco: Aspetti Tecnico Scientifici Regolatori Ed Etici, 29/30 from Università Cattolica Del Sacro Cuore.
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