With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries. At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves. This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases. Recordati. Unlocking the full potential of life.



Job Purpose We are looking for a Regulatory Affairs CMC Specialist who has consolidated experience on Chemistry, Manufacturing and Control (CMC) aspects in order to manage the preparation of dossiers for submission to regulatory authorities worldwide. Key Responsibilities Writing and managing technical sections of Module 3 in collaboration with relevant departments/functions Assessment of documentary/technical gaps associated with existing products, processes and methods (Gap Analysis) Evaluation of technical reports (Process Validation Protocols & Reports, Analytical Methods Validation, AMT, Development Reports, TT) Competence on how to translate technical reports into regulatory documents suitable for submission to the Regulatory Authorities Assessment of Modules 3 of existing products in order to predict the potential future regulatory impact associated with those products and related variations Conduct regulatory assessments for CMC change c

📌 Regulatory affairs cmc specialist (Italia)
🏢 Recordati
📍 Italia