European Regulatory Affairs Limited (trading as Ivowen), Managing Director; Vale Pharmaceuticals Limited, Managing Director;
Smart Pharma Limited, Managing Director
Started in Pharma Regulatory Affairs over 14 years ago, initially in a manufacturing facility in Ireland. Joined Ivowen regulatory affairs consultancy over nine years ago and became Regulatory Affairs and Business Manager after four years. Became Managing Director and owner of the consultancy in 2021.
Experienced in managing EU compliant dossiers (Modules 1 – 5) including compliance, DCP/MRP variation applications, Regulatory Strategy for the EU and Accession Territories, including in-licensing, Quality Overall Summaries for human and veterinary medicinal product applications and Type II variations, Paediatric Investigation Plans (PIPs) for new fixed combination applications and Paediatric Use Marketing Authorisations (PUMAs), Clinical Trial Applications, including the Voluntary Harmonisation Procedure (VHP), Orphan designation applications, Scientific advice and pre-submission meetings with the EMA and national Competent Authorities, Running and support of Centralised Procedure, Decentralised Procedure and Mutual Recognition Procedure, and national applications, eCTD software and lifecycle management, Quality Management System and SOPs incorporating regulatory affairs, pharmacovigilance, quality and admin functions, Team and Human Resource Management of varying levels of experience and job descriptions and responsibilities
Qualifications include a degree in Environmental and chemical science as well as a certificate in counselling. Pre-pharma experience includes working as an Environmental Laboratory technician, Quality Control Analyst and Scientific Information Specialist (processing and reviewing published literature for inclusion in a searchable database tool).