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.
• 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.
• 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.

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.

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.

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.

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