Leuven, Flemish Region, Belgium
PERSONAL STATEMENT International Regulatory Affairs leader with proven ability in global regulatory teams of developing and implementing global regulatory strategies enabling successful product launches and commercialisation. Passionate about bringing products to market to improve patient outcomes. More than 30 years pharmaceutical industry experience across multiple geographic regions (including Europe, Japan and North America) and focus areas, with experience in non-clinical pharmaceutical R&D labs. Specialist in providing multidisciplinary international matrix teams with regulatory leadership. Extensive experience with hands-on contributions to regulatory filings, from due diligence through to product divestment. Native English speaker, fluent in German (C2 level, German citizenship)
• Independent Regulatory Affairs consultant offering a comprehensive range of regulatory support • Non-clinical expert (PhD. 20 years pharma R&D lab experience) • Maintenance of Marketing Authorisations and licence variations & renewals • Assisting in the preparation and submission of regulatory applications (new submissions, renewals, variations, eCTD, National, MRP & CP etc.) • SmPC harmonisation • PIL user-testing • Designing, developing & maintaining client regulatory database • Collecting submission data and regulatory intelligence • Undertaking ad hoc projects as required to support the RA team • Keeping up to date with international legislation, guidelines and customer practices by attending courses, seminars and reading guidelines, directives and articles • Maintaining quality systems • Presenter at TOPRA Basics of Regulatory Affairs Course (pre-clinical drug discovery)