Extensive, diverse experience in large, mid-sized and small pharmaceutical companies with emphasis on drug development and strategic management of drug registrations in the U.S. and Europe. Successful in leading regulatory groups of various sizes, from established departments to start-ups. Major product brands experience include Alesse, Aricept, MultiHance , EZHD, Fenoglide, LCP Tacro, Prilosec, Vantas, Supprelin LA, Valstar and Zenpep.
Specialties: Regulatory Affairs and Drug Development working for both U.S FDA and EMA.
Therapeutic Areas: Neurology, Psychiatry, Gastrointestinal, Oncology, Transplantation, Respiratory, Men and Women's Health and Pain/Analgesics.
Expertise: U.S. INDs,...
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