Manuela Brugnolotti

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Manuela Brugnolotti

Località: 53034 Colle di Val D'Elsa (SI), Italy
Job: Consultant for Regulatory Affairs, QA, QC & Production
Associazioni: Member of the Italian Society for Regulatory Activities (SIAR)
Studi:  Pavia University (Organic Chemistry, Pure & Applied Chemistry)
Status: Freelancer
Lingua: Italian (First language), English (Fluent)
Esperienza:   (Consultant for Regulatory Affairs, QA, QC & Production), Novartis Vaccines and Diagnostics (Regulatory Affairs Head of Flu & Respiratory Franchise), chiron Vaccines (Regulatory Affairs Head of Flu & Respiratory Franchise), Chiron Vaccines (Regulatory Affairs Manager), Helsinn HealthCare (Regulatory Affairs Manager), Pharmacia &a...
Cerco: Companies that need a Regulatory Affairs consultant for Regulatory Affairs, Quality Assurance and Production activities
Offro: a) regulatory activities: preparation of regulatory strategies for developments projects and marketed products, preparation of the CMC documentation for regulatory submissions such as licence applications, variations, PAS, CBE30, annual report, renewals, IMPD, etc, preparation of documentation for meetings with main Health Authorities (EMEA, FDA, European national Authorities, TGA, etc.) such as s...
Interessi: reading, music, art, travelling

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Manuela Brugnolotti

Locality: Florence Area, Italy
Summary: regulatory activities: preparation of regulatory strategies for developments projects and marketed products; preparation of documentation for submissions; preparation of documentation for meetings with main Health Authorities such as scientific advice, pre-reads for type C meetings, etc; preparation of meetings with main Health Authorities and rehearsal; provide regulatory review to regulatory documents; liaise with other departments in the company in order to obtain all the necessary information required for regulatory submissions; liaise with other third party manufacturers and/or suppliers in order to get all relevant information/documentation for regulatory submissions; provision of regulatory advice and guidance to other departments (e.g. Quality Assurance, Production, Quality Controls, etc) and to quality/production documents; interpret and anticipate implications of new guidelines; troubleshooting and problems solving; (contribution) set-up of regulatory organization/department; regulatory training for junior positions. Evaluation of regulatory docs for due diligence. QA activities: critical analysis of quality documentation such as validation protocols, validation reports, SOPs, etc.; training on GMP guidelines; implementation and management of quality integration projects on various sites; production activities: input regarding preparation of production documents and position papers. Goals: Quick preparation and implementation of solutions in critical situations first to market with flu vaccines and successful approvals of critical changes with aggressive timelines. 1st electronic submission in Italy (1993), optical archive management
Past: Regulatory Affairs Head of Flu & Respiratory Franchise at Novartis Vacines & Diagnostics Regulatory Affairs Head of Flu & Respiratory Franchise at Chiron Vaccines Regulatory Affairs Manager at Chiron Vaccines Regulatory Affairs Manager at Helsinn Healthcare Regulatory Affairs Area Manager for Eastern Europe at Pharmacia & Upjohn Regulatory Affairs Manager at Pharmacia Regulatory Affairs Officer at SmithKline Beecham Research Manager at SmithKline Beecham Researcher at Farmitalia Carlo Erba Postgraduate scholarship at University of Milan Postgraduate at University of Pavia see less... 8 more...
Education:  Universit degli Studi di Pavia Organic Chemistry (1979-1985) Publication: M. Brugnolotti, A. Corsico Coda, G, Desimoni, G. Faita, A. Gamba Invernizzi, P.P. Righetti and G. Tacconi: Diels Alder versus heterodiene in the reaction between 4-arylidene-5-pyrazolones and 2,3-dimethylbutadiene: the effect of acid catalysis, Tetrahedron, 44, 5229-5242, 1988.

Industry: Pharmaceuticals
Skills: Problem solving, negotiation, merger and acquisition, training, budget management, preparation and management of meetings with Health Authorities, leadership,
Experience: Art in Science, Consulting Services for Bio & Pharma (Pharmaceuticals industry): Consultant for regulatory affairs, QA, production,  (August 2007-Present) RA: prep. regulatory strategies for develop. & marketed products; prep. CMC doc. for RA submissions (e.g. licence applications, variations, PAS, CBE30, annual report, renewals, IMPD); prep. docs for meetings with main...
Interests: consulting offers, new ventures, expertise requests, reference requests, getting back in touch

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