• >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