A highly experienced Regulatory Professional working on global, complicated regulatory projects as part of a team. Leading on European Regulatory Agency interactions, International Regulatory Affairs. Working as Global Regulatory L:ead or European Regulatory Lead. Broad experience his highly valuable to small and medium enterprises as they need experience in all aspects of the regulatory submissions and related activities. Experienced in the preparation of submissions for clinical trials, Paediatric Investigation Plans, SME. Orphan Designations, Biomarker and Marketing Authorisation applications for new chemical entities and biologicals. Medical writing for clinical trials and regulatory submissions. Working on all sections of the dossier CMC/Quality, Non-Clinical and Clinical. Extensive experience at quality audits, past roles as responsible person and leading CAPA analysis and correction activities. Significant experience in investment of new products, technology, business transfers or divestment.Specialties: Paediatrics, Orphan Drugs and rare disorders including stem cell treatments and gene therapies , cardiovascular, metabolic diseases,oncology, neuromuscular disorders, radiopharmaceuticals and devices