Senior Manger
SANOFI
Licensed pharmacist with more than 10 years experience in regulatory affairs and drugs development; with professional expertise in regulatory strategies from early-stage development to marketed products in oncology, CNS and anti-infective drugs.
Proven experience in new medicinal products registration and MA life-cycle management (CMC/safety changes/labeling changes) in major markets (FDA, EMA, Emerging markets HAs).
Provide regulatory intelligence and regulatory strategies to senior leadership team and product development teams on up-coming regulation and policy emerging trends (ICH, FDA, EMA) with emphasis on advanced therapies (gene and cell therapy) and clinical development.
Disclosure information not submitted.
Data at the Core: Understanding Your Company's Critical Yet Underutilized Tool
Wednesday, May 8, 2024
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