Edy Vastano
Regulatory Affairs senior Specialist
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Info
Mi considera una persona flessibile e dinamica, orientata al lavoro in team e al conseguimento degli obiettivi entro i tempi richiesti. Completano il profilo precisione e affidabilità.
Esperienza
CAI
03/2023 -up today
CTD writing (Mod.2-3)
Gap assessment and Regulatory strategy
Project Management
Mediator at workshop
Pierrel S.p.A.
12)2017-03/2022
Management
Management of 3 resources; Interfunctional coordination for regulatory projects; Project Management; Due Diligence; Relations with regulatory agencies; Budget; Quotations
Regulatory Affairs as Regulatory Affairs Manager
New registrations by Eu-DCP/RUP and NP (Far East, Middle East, East, Europe, Africa, North America); Renewals and Variations; Preparation of dossier in CTD format (Module 1 e Quality Part), revision and update of Clinical and Pre-clinical part of CTD; Preparation of Response Documents concening DL received from HAs (Quality, pre-clinical e clinical part); Activities related to the management and update of printed materials; Notification to Data Bank
Cmo
Relationship with customers and regulatory support concerning new registration applications and MA manintenance, Changes related to the manufacturing site (ME/MNE); Regulatory compliance; Change control; SOPs e working instructions.
Pharmacovigilance as QPPV Deputy
Update of PSMF, daily reconciliation of iCSRs, quarterly reconciliation, Preparation of PSUR, ASR Canada e PADER US, SDEA, safety variations sosepharm S.r.l.
03/2013-11/2017
Regulatory Affairs
Medicinal products –Italia
Renewal and Variations
Medicinal products – Foreign markets
New registration procedures (Far East; East; Middle East; Europe; Africa; Central America; South America), Renewal and Variations, Preparation of dossier in CTD format (Module 1 e Quality Part), Preparation of Response Documents concening DL received from HAs (Quality, pre-clinical e clinical part)
Medical Devices, Class 1
New registrations in Italy and foreign markets; Notifications for Variation to the MoH in Italy and foreign markets; Preparation of the Technical File; Advertisement for the Italian market
CMO
Regulatory support to the customers relating to Renewal and variation for medicinal products and medical devices registered in Italy and abroad; Preparation of response documents for deficiency letters received from health authorities for medicinal products registered in Italy and abroad; Regulatory support to the customers relating to new registrations for foreign trades). Change controls; Rapid Alerts; Preparation of SOPs and working instructions; Technical agreements; Regulatory Compliance
Scientific service, as Responsible Person
Notification to AIFA of the medical sales representative list; periodic trainings to the ISF; preparation and submission of marketing materials; Internal audits and annual inspection to renewal of ISO Certification, notification to AIFA related to Events and Conventions; transfert of economical value.
Biopharma S.r.l.
10/2011-03/2013
Regulatory Affairs
Business Company
MA Maintenance for medicinal products registered in Italy (Renewal and variation); Update of dossier sections in CTD format; Update of data banks, Sunset clause; Regulatory archive; Update of ANDA AR for products registered in US; New registrations in Switzerland).
CMO
Update of SMF; Request of Certificates for pharmaceutical Products; Request of Manufacturing Licence and GMP Certificates; Change controls; Review of artworks, Update of DMF AR for products registered in US, Relationship with customers
Market access
Prices and Payback, Preparation of Price dossier
Formazione
Laurea in ctf - università degli studi di Napoli - 12/2008
Master in affari regolatori - università degli studi di Pisa - 07/2011
Master in Pharmaceutical and Healthcare Business Administration - LUISS Business School - 12/2013
