Paul Hajdukiewicz

Paul Hajdukiewicz

Regulatory Affairs Manager

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  • Timeline

  • About me

    Director Global Regulatory Affairs

  • Education

    • University of London

      -
      Bachelor of Science (BSc) Joint Hons Human Anatomy, Physiology & Biochemistry; Contract Law, Criminal Law & ELS
    • University of Oxford

      -
      MSc Neurophysiology
  • Experience

    • Stafford Miller Ltd.

      Oct 1992 - Aug 1995
      Regulatory Affairs Manager

      Responsible for International Regulatory Affairs for Rx and OTC medicines, Medial Devices, Cosmetics, Pesticides and Household Products in the UK and Company's export markets.

    • Block Drug Company Inc.

      Aug 1995 - Jan 2001
      Director International Regulatory Affairs

      Responsible for International Regulatory Affairs for Rx and OTC medicines, Medical Devices, Cosmetics, Pesticides and Household Products

    • GSK

      Jan 2001 - Jan 2015
      Director Global Regulatory Affairs

      Responsible for Medicines Cosmetics Pesticides and Medical Devices Class !, IIa and IIbRisk analysis ISO 13485 compliance Notified Body audits US Labelling IND NDA Annual Reports Global Regulatory Performance metrics

    • Contractor

      Aug 2015 - Dec 2015
      Global Regulatory Affairs Consultant

      ANDAs SVPs Modules 1 2 3 Global Regulatory metrics, IND and NDA annual reports, Labelling and Promotional material approval, medicines, medical devices, cosmetics and pesticides

  • Licenses & Certifications

    • RAC (EU)

      RAPS
    • RAC (Global)

      RAPS
    • RAC-EU

      REGULATORY AFFAIRS CERTIFICATION PROGRAM
      Dec 2011
      View certificate certificate