Jimmy Wong

FAQ About Jimmy Wong

• What is Jimmy Wong's address?

  Jimmy Wong is located at
  Amersham, Amersham, United Kingdom

• What is Jimmy Wong's job title?

  Jimmy Wong is a
  A broad career experience with over 20 years European and International Regulatory Affairs and Quality Systems (ISO 13485, 9001 & 13488) 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). 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 US FDA 21 CFR 820 regulation, 510K, PMA, IDE, De Novo, CLIA88, LDT, Biomarker Qualification Program. MDD and MDR General Medical Devices ​Class I, II, III & sterile devices and drug combination devices IVDD and IVDR In vitro Diagnostic Devices ​Class I, IIa & IIb (revised classification A, B, C and D) Specialties: Heamatology and Oncology Novartis Vaccines And Diagnostics

• What industry does Jimmy Wong currently work in?

  Jimmy Wong currently works in the
  Novartis Vaccines And Diagnostics

• What is Jimmy Wong's area of expertise?

  Jimmy Wong specializes in
  A broad career experience with over 20 years European and International Regulatory Affairs and Quality Systems (ISO 13485, 9001 & 13488) 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). 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 US FDA 21 CFR 820 regulation, 510K, PMA, IDE, De Novo, CLIA88, LDT, Biomarker Qualification Program. MDD and MDR General Medical Devices ​Class I, II, III & sterile devices and drug combination devices IVDD and IVDR In vitro Diagnostic Devices ​Class I, IIa & IIb (revised classification A, B, C and D) Specialties: Heamatology and Oncology

• Which languages does Jimmy Wong speak? 

  Jimmy Wong speaks the following languages:
  No languages available.

• Which industries has Jimmy Wong previously worked in?   

  Jimmy Wong has prior experience in the following industries:
  Ppd , Regulatory Affairs Independent Consultant , Ezem , Bristol Myers Squibb , Remel And Oxoid , Medicines Control Agency , Ias Environmental Consultant , Royal Cornwall Hospital Trust

• What is Jimmy Wong’s work experience?  

  Jimmy Wong has the following professional experience:
  Novartis Vaccines And Diagnostics , Ppd , Regulatory Affairs Independent Consultant , Ezem , Bristol Myers Squibb , Remel And Oxoid , Medicines Control Agency , Ias Environmental Consultant , Royal Cornwall Hospital Trust , Novartis .

• How can I find Jimmy Wong on LinkedIn?  

  You can view Jimmy Wong’s
  LinkedIn profile at LinkedIn URL.

• What are Jimmy Wong’s work email addresses?  

  Jimmy Wong’s work email addresses are
  [email protected] .

• What company does Jimmy Wong work for?  

  Jimmy Wong works at
  Novartis Vaccines And Diagnostics