Succefull global regulatory filing and approvals of NDA, sNDA, EU MAA, MRP and Japanese MHW in CNS, Cardiovascular, Oncology, Anti-infection, Hypertension, and other therapeutic areas.
Extensive management experience in pharmaceutical development, in-licensing evaluations, global medical affairs, and global marketing with Phase 3B studies, post-marketing Phase 4 studies , labeling studies, publications, professional education, medical information and all activities in life cycle management (LCM).
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