Joseph Irwin
Senior Consultant - Regulatory Affairs @Greyrigge Associates
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WORK HISTORY
Senior Consultant - Regulatory Affairs @Greyrigge Associates
Skills include:Preparation of submissions for clinical trials, including Paediatric Investigation Plans, Orphan Designations, Biomarker and Marketing Authorisation applications for new chemical entities and biologicals Medical writing for clinical trials and regulatory submissions Populating CMC/Quality, Non-Clinical and Clinical sections of regulatory dossiers Performing quality audits as Responsible Person and leading CAPA analysis and correction activities Due diligence of new products, technology, business transfers or
EDUCATION
University of Leeds
BSc, Biochemistry-Pharmacology Combined Hons
Birkbeck, University of London
MSc, Biomolecular Organisation
SKILLS
ABOUT JOSEPH IRWIN
A highly experienced Regulatory Professional working on global, complicated regulatory…
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