Joseph Irwin

Senior Consultant - Regulatory Affairs @Greyrigge Associates

Hemel Hempstead, GB
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2024 — Present

Senior Consultant - Regulatory Affairs @Greyrigge Associates

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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

1980 — 1983

University of Leeds

BSc, Biochemistry-Pharmacology Combined Hons

1986 — 1988

Birkbeck, University of London

MSc, Biomolecular Organisation

SKILLS

PharmacovigilanceCns DisordersGmpIch-GcpClinical DevelopmentCvsVaccinesRegulatory SubmissionsCtmsRegulatory AffairsLifesciencesLife SciencesGeneric ProgrammingEmeaDrug DevelopmentGcpClinical TrialsNeurological DisordersPharmaceutical IndustrySopFdaOncologyRegulatory RequirementsIndBiotechnologyPharmaceuticsMedical DevicesClinical ResearchPediatricsEuropean UnionEctdEmaHematologyTechnology TransferQuality Assurance

ABOUT JOSEPH IRWIN

A highly experienced Regulatory Professional working on global, complicated regulatory…

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Joseph Irwin — Senior Consultant - Regulatory Affairs at Greyrigge Associates in Hemel Hempstead, GB | Unifers