Claire Corinne Azzopardi

Claire Corinne has over 25 years’ experience in regulatory affairs, acquired through 17 years of employment in the pharmaceutical industry and 6 years in regulatory consultancy.  

Her expertise covers various aspects of Regulatory Affairs with a particular focus on Chemistry, Manufacturing and Control (CMC) as well as EU and UK regulatory procedures, with experience spanning early pharmaceutical development, marketing authorisation applications and post-marketing lifecycle management.  

Claire’s main area of expertise is in EU and UK regulatory affairs, with a strong focus on Chemistry, Manufacturing and Control (CMC). She has extensive experience in regulatory processes and procedures, including supporting pharmaceutical development, preparing and publishing regulatory dossiers (IMPDs, CTD Modules 1 and 3 and Quality Overall Summary, and MAAs via CP, DCP, MRP, and national procedures), and ensuring compliance with current regulatory requirements through dossier review and updating. She has extensive experience in managing CMC deficiency responses and in developing effective strategies to address regulatory authority questions. She works across a wide range of product types, including small molecules, biologics, oral solid dosage forms, semi-solid dosage forms, suppositories, ophthalmic solutions, and injectables. She is experienced in the use of EMA platforms such as EudraCT, PLM Portal and SPOR, as well as the UK MHRA Submission Portal and the Common European Submission Portal (CESP). She also provides client training and support on regulatory processes and represents clients in regulatory interactions with Competent Authorities. 

Claire’s previous experience in the pharmaceutical industry includes Chemistry, Manufacturing and Control (CMC), EU regulatory affairs, supporting pharmaceutical development from a regulatory perspective, Module 3 audit, risk assessment, gap analysis and upgrading, dossier compilation (Modules 1, 3 and QOS), responding to CMC deficiency letters, life cycle management and also project and team management. Claire has also gained experience in international regulatory submissions and procedures in Japan, Canada, Australia, Latin America and the Middle East. Her background also includes project and team management.