Title Regulatory Affairs CMC Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78f6kg

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 controls Required Education Degree of chemistry,



pharmacist or biotechnology Required Skills and Experience The figure sought is a Specialist in the Regulatory CMC sector with an extremely technical cut who has previous business experience (eg manufacturing Compliance, Regulatory CMC). 3+ years working experience in CMC regulatory affairs The resource must have adequate skills to understand and deal with the "intelligent and targeted" writing of a section of Module 3 in order to place in it the correct information expected by Regulatory Authorities. The resource must know the guidelines governing the CMC sector, such as GMP, ICH Q, EMA Quality guidelines, WHO guidelines and must be able to interpret these guidelines according to the product to be managed. analytical chemistry / CTD / manufacturing environment / medical devices / GMP / ICH – Regulatory guidelines/ Eur. Ph. /technical transfers Required Behaviours and Competencies * Positive thinking and behaviour * Effective presentation and communication skills * S

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78f6kg