
Paul Hajdukiewicz
Regulatory Affairs Manager

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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 1995Regulatory Affairs ManagerResponsible 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 2001Director International Regulatory AffairsResponsible for International Regulatory Affairs for Rx and OTC medicines, Medical Devices, Cosmetics, Pesticides and Household Products

GSK
Jan 2001 - Jan 2015Director Global Regulatory AffairsResponsible 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 2015Global Regulatory Affairs ConsultantANDAs 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- View certificate

RAC-EU
REGULATORY AFFAIRS CERTIFICATION PROGRAMDec 2011
Languages
- enEnglish
- frFrench
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