Global regulatory affairs professional having more than 9 years of experience specifically focused on clinical trial applications for New Molecular Entities (NME) in global region mainly Asia-Pac, EU and US, drug, OTC, cosmetic registrations.
Specialties: Expertise in clinical development of NCEs/NBEs (Early phase (Phase I) to late phase (Phase 3) clinical studies). Drugs, OTC and cosmetic registration
Global regulatory affairs activities including global regulatory strategy, development of target product profile, preparation of high quality regulatory dossier for filing clinical trial application of NCEs/NBEs, regulatory intelligence, assist in development of regulatory strategies for...
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