Barbara Vecchi Email & Phone Number

My name is Barbara Vecchi, and I am driven to continuously challenge myself. I seek to further my career in a dynamic work environment alongside dedicated professionals who are passionate about their work. I enjoy collaborating with teams to achieve success for the company and satisfaction for our customers.I have been employed at Lusochimica for over twenty years, working in the Quality Assurance and Regulatory Affairs department. During this time, I have gained extensive experience in the field of Active Pharmaceutical Ingredients (APIs). For the past six years, my focus has been on Regulatory Affairs, which includes submitting ASMF/DMF to European countries under National, Centralized, Decentralized, and Mutual Recognition Procedures, as well as to ROW countries, including the US under NDA and ANDA Procedures.Since September 2020, I have held the position of Regulatory Affairs Manager for all three Lusochimica sites located in Lodi, Lomagna, and Pisa. Prior to this role, I served as the Regulatory Affairs Coordinator for the same three sites, which allowed me to develop both personally and professionally as a manager. Between 2013 and 2020, I worked as the QP Deputy and QA & RA Deputy Manager at the Pisa site.In collaboration with our parent company, Menarini, I initiated and spearheaded a project to adopt docuBridge for the execution and publishing of eCTDs. Furthermore, I am currently implementing the validated software system used by Menarini for the execution, management, and archiving of ASMFs/DMFs at Lusochimica.I specialize in Regulatory Compliance and have gained considerable experience in redefining regulatory starting materials and intermediates, as well as in the control strategy of genotoxic impurities, nitrosamines, and elemental impurities.I regularly communicate with clients and regulatory agencies from around the world in English, having achieved a B2 level of proficiency in the language. I have also had the opportunity to participate in business trips to Italy, Europe, Japan, and the United States.

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  Chimica E Tecnologie Farmaceutiche (Universita' Pisa)