Anna Nicoletti Email and Phone Number
Anna Nicoletti work email
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Anna Nicoletti personal email
Group Coordinator, Senior Scientist Leader and Regulatory Affairs Senior Specialist with many years of experience in managing Research and Development projects at International Pharmaceutical Companies and Contract Manufacturing Organizations; I believe I can offer extensive managerial and technical skills (team management, analytical laboratory supervision, Good Manufacturing Practice compliance). I am a resource who for years has managed people, traveled, worked in R&D and in close contact with the QC/QA/RA functions, interacted with outsourced subcontractors. I have a set of outstanding soft skills, such as assertive leadership, motivation in challenging situations and the creation of synergistic teams, which allow me to achieve important goals by making the most of resources.
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Regulatory Affairs Senior SpecialistF.I.S. - Fabbrica Italiana Sintetici S.P.A. Jan 2022 - PresentMontecchio Maggiore, Veneto, ItalyI manage all the regulatory aspects of the projects, both human and veterinary, in the clinical phase and in the commercial phase of the custom manufacturing field.• Facilitate and direct communication between internal functions (Production, Sales Management, R&D, Quality Assurance, Quality Control) with the aim of ensuring the correct alignment of technical information with the requirements of the competent authorities.• I deal with: dossier preparation (eCTD), import of active substances, deficiency letters, change control management, review of nitrosamine risk assessments, preparation of risk assessments for the use of multipurpose plants. I actively collaborate within the regulatory function to facilitate training and the growth of technical skills.• Strengthen the Quality and Regulatory aspects in the project teams -
Senior Scientist Analytical LeaderF.I.S. - Fabbrica Italiana Sintetici S.P.A. Jul 2018 - Dec 2021Lonigo, Veneto, ItalyCoordination of the integration process between the Montecchio Maggiore site, headquarters, and the Lonigo site and Senior Scientist Leader in the management of both human and veterinary custom projects.• Provided GMP training.• Managed outsourcing activities assigned to CRO/CMO in Italy and India, bringing them up to speed under my coordination.• Technology Transfer supervisorI led a group of five people respecting the area % goal ; I actively participated in the sharing of technical and process know-how among the various sites dedicated to the same project. I fostered a productive collaboration with all internal functions, which led to final outputs in line with the specific requests of external and internal customers (Production, Quality Control, Quality Assurance and Regulatory Affairs). I strengthened my skills in Regulatory Affairs and Quality Assurance. I personally managed deviations and resolved out of trend, in order to prevent critical issues impacting production in advance. I have always participated in inspections by customers/regulatory authorities
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Senior Scientist Analytical Leader In New Generics Launching UnitF.I.S. - Fabbrica Italiana Sintetici S.P.A. Jun 2016 - Jul 2018Montecchio Maggiore, Veneto, ItalyI coordinated a group of five people respecting the target percentage of achievement of the projects' objectives.• Development and validation of analytical methods.• Development and validation of cleaning methods• Forced degradation studies.• Issuing of transfer protocols and reports.• Management of regulatory dynamics.• Application of Good Manufacturing Practice.I strongly strengthened my skills in Regulatory Affairs. I managed the outsourcing activities in Italy, Canada and India in compliance with the specific requests, through on-site trips. I leaded 5 collaborators, both senior and junior, in the development and validation of analytical methods.
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Analytical Development Senior ScientistF.I.S. - Fabbrica Italiana Sintetici S.P.A. Nov 2010 - Jun 2016Montecchio Maggiore, Veneto, ItalyI coordinated a group of four people. Responsible for planning and monitoring times-costs-resources assigned to all analytical activities to support custom projects , both for early and late phase. Responsible for the review and presentation of analytical data. I worked according to GMP. I collaborated with Quality Control, Quality Assurance and Regulatory Affairs functions in the documentation review/preparation process, also in preparation for second/third party audits. I coordinated outsourced projects.
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Senior Scientist In Analytical SciencesAptuit Jul 2010 - Nov 2010Verona, Veneto, Italy -
Senior Scientist In Analytical SciencesGlaxosmithkline Apr 2004 - Jul 2010Verona, Veneto, ItalyManagement of late-development pahse clinical projects.• Development and validation of analytical methods.• Drafting of transfer protocols and reports.• Application of Good Manufacturing Practice.• Application of modern Design for Manufacturing principles and ICH guidelines.• Technology Transfer SupervisorFor about two years I worked as technology transfer manager from R&D Verona to R&D UK and GlaxoSmithKline Manufacturing Singapore, spending some periods permanently abroad. For about a year and a half I held the role of lead user of the laboratory information system (LIMS). -
Scientist In Analytical SciencesGlaxosmithkline Sep 2002 - Apr 2004Verona, Veneto, ItalyI worked on early-development phase projects. I have been included in a comprehensive training program : development and validation of analytical methods, management and team coordination, quality aspects, internal auto-inspections, preparation of regulatory documents, review of laboratory standard procedures.
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Laboratory TechnicianNewchem Spa Sep 2000 - Sep 2002Verona, Veneto, Italy
Anna Nicoletti Education Details
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Analytical Chemistry -
Bachelor'S Degree
Frequently Asked Questions about Anna Nicoletti
What company does Anna Nicoletti work for?
Anna Nicoletti works for F.i.s. - Fabbrica Italiana Sintetici S.p.a.
What is Anna Nicoletti's role at the current company?
Anna Nicoletti's current role is Regulatory Affairs Senior Specialist at FIS ( Fabbrica Italiana Sintetici).
What is Anna Nicoletti's email address?
Anna Nicoletti's email address is an****@****bal.com
What schools did Anna Nicoletti attend?
Anna Nicoletti attended Università Degli Studi Di Pavia, Eindhoven University Of Technology, Università Degli Studi Di Padova.
Who are Anna Nicoletti's colleagues?
Anna Nicoletti's colleagues are Christian Franceschini, Daniela Centurione, Matteo Bruni, Davide Tumini, Andrea Francesco Landucci, Guido Di Muccio, Francesco Castellini.
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