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Professional/Management competencies: • >20 years experience in the pharmaceutical industry with >10 years of Management experience in Regulatory Affairs and Pharmacovigilance with 5-34 reports • Regulatory Project Manager leading complex cross-Atlantic project team. • All round international regulatory experience with Life Cycle Management of products and specialised regulatory expertise in drug development and regulatory strategic thinking • Knowledge from drug development areas outside Regulatory Affairs, i.e. Pharmacovigilance and Clinical Operations • Effective in building relationships and negotiating with Regulatory agencies worldwide • International experience working three years in the UK and two years in the US • Experience within several therapeutic areas: fertility, obstetrics, urology, oncology, CNS, diabetes, and haemostasis • External involvement incl. course and conference leaderships and lecturing on an ongo-ing basis. Leadership and personal competencies: • Commitment to business focus • Set targets and direction effectively • Coach and develop individuals and teams to optimise performance through professional insight, empowerment, enthusiasm, and ‘walk the talk’ • Navigate and facilitate organisational change and ensure continuous improvement • Combine out-of-the-box thinking with pragmatic problem solving