Anna Nicoletti Email & Phone Number

Montecchio Maggiore, Veneto, Italy

I 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

Lonigo, Veneto, Italy

Coordination 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

Montecchio Maggiore, Veneto, Italy

I 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.

Montecchio Maggiore, Veneto, Italy

I 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.

Verona, Veneto, Italy

Verona, Veneto, Italy

Management 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).

Verona, Veneto, Italy

I 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.

Verona, Veneto, Italy

Education record

Post-Graduated Master Regulatory Affairs

Analytical Chemistry

important in view of the growing interest in biomass gasification, use of a pulsed corona techniques in biogas cleaning and removal of VOCs

Bachelor'S Degree