Tailored, solution driven, European regulatory strategy consultancy services for (bio)pharmaceutical and biotech industry
Former European deputy therapeutic area head with over 20 years European/European Middle East Africa (EMEA) regional regulatory experience, with a proven ability to lead and manage teams through complex regulatory submissions and Health Authority (HA) interactions. This includes over 15 years European/EMEA regional regulatory lead experience. Worked closely with global multifunctional and country teams in developing and executing regional regulatory strategies. Successfully led regional regulatory activities and HA negotiations for over 50 innovative products in various therapeutic areas of (immuno-)oncology, hematology, metabolic/cardiovascular diseases, immunology, and virology across different stages of development and life-cycle management. Represented Bristol-Meyers-Squibb at Cancer Drug Development Forum. Have strong interests in drug development including pediatric and rare diseases, and innovation.