Senior Manager, Global CMC Regulatory Affairs
Prepares the regulatory dossier related to Chemistry, Manufacturing and Controls, CTD-Module 3, Module 2.3 (QOS) or appropriate documentation needed for registration of drugs for worldwide Regulatory Authorities. To this scope the job holder cooperates and interacts, within working groups, with manufacturing sites and Quality Assurance (QA) of Bracco Group and external companies (e.g. contract manufacturers), by providing his own advice from the regulatory prospective and by requesting the necessary technical documentation from other internal and external functions.
Continuous update of CMC regulatory requirements by researching and sharing rules and guidelines worldwide.
Oversees the process of submissions of Variations to the Regulatory Authorities and prepares Variation/Supplements or appropriate documentation (dossier related to changes/updates for delivery to regulatory authorities after the registration of product) related to chemical-pharmaceutical production by interacting with production sites concerned.