Regulatory Affairs Senior Manager, Professional Speaker and Trainer
Industry
Medical / Health Care / Pharmaceuticals
About
I am a detail-oriented and self-motivated regulatory affairs senior manager with 10+ years of experience in both small and large molecule drugs. Thanks to my strong background in R&D, CMC and clinical trials, I lead the role of 鈥淏ridge builder鈥� to keep the balance of regulatory requirements between the pharmaceutical companies and the government agencies. My capability includes but is not limited to CMC authoring, submission dossiers preparation and strategy development for CTA/ MAA/variations, PSURs, renewals, lifecycle management, eCTD submissions, Q&A to NCA, regulatory submission dossier review and compliance (GMP Clearance, gap analysis) for EU, US, Canada and emerging markets, proje...
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