Jimmy Wong Email Address

Director of Regulatory and Scientific Affairs, APAC

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A broad career experience with over 12 years European and International Regulatory Affairs and 5years Quality Systems (ISO 13485:2003, 9001:2000 & 13488:1996) experience and in addition CMC, GMP, Internal Auditing, European Clinical Trial Phase I, II, III & IV, Project development Management, Pharmaceutical Risk Management Plan and Medical Device Risk Analysis (ISO 14971:2003). Regulatory Affairs experience with European and International Clinical Trial Authorisation, Marketing Authorisation and Post-Marketing in both chemical and biological drug products via the Centralised, MRP and National procedures involving varies European Member States as the Concern Member state and Reference member state. I also have experience in writing CTD, IMPD, Afssaps viral safety application and Clinical Trial substantial amendments, scientific advice experience with the UK MHRA, Irish Medicine Board and CBG Netherlands, as well as experience with User testing of Patient information Leaflet and QRD for SmPC, Labelling and Package Leaflet. In addition to the above experience, I have experience in reviewing advertising, marketing and promotional materials from a regulatory perspective. I have also prepared IND, NDA, BLA and ANDA application to the US FDA Specialties: Heamatology and Oncology