Chineham, Hampshire, United Kingdom
Regulatory Affairs Manager CMC at Shire
Pharmaceuticals
Education
Regulatory Affairs Certification (RAC) EU regulations
Professional certification, Regulatory Affairs
École polytechnique fédérale de Lausanne
Regulatory Affairs
Rijksuniversiteit Groningen / University of Groningen 2005 — 2010
Doctor of Philosophy (PhD), Pharmaceutical biology, Molecular biology, Biotechnology, Protein biochmistry, Plant physiology.
Kihara Institute for Biological Research, Yokohama, Japan 2009 — 2010
Intern, Pharmaceutical biology
RIKEN, Wakoshi, Japan 2008 — 2009
Intern, Protein biochemistry
Plant Research International, Wageningen, The Netherlands 2007 — 2008
Intern, Plant physiology
Cold Spring Harbor Laboratory, New York, USA
Intern, Yeast and molecular plant biology
Experience
Shire May 2015 - Present
GlaxoSmithKline July 2013 - April 2015
Sandoz November 2012 - January 2013
Kelly Scientific/Novartis September 2012 - September 2012
National Cancer Center Research Institute September 2010 - August 2012
Skills
Strategy, GMP, Molecular Biology, Variations, Regulatory Submissions, Renewals, EU regulations, Compliance, Biotechnology, Drug Discovery, Oncology, Regulatory Affairs, RoW regulations