Gent Area, Belgium
Senior Manager Regulatory Affairs & Compliance at Amgen
Pharmaceuticals
Education
IFB 2008 — 2008
Pharmaco-economics and Disease management
IFB 2007 — 2008
Master, Management Course Pharmaceutical Business
2004 — 2005
Master, Business Administration
Ghent University 2000 — 2001
Master, Pharmaceutical Biotechnology
Universiteit Gent 1995 — 2000
Master, Pharmacist
Don Boscocollege 1989 — 1995
High School, Maths - Sciences
Experience
Amgen May 2010 - Present
Janssen-Cilag November 2009 - May 2010
Janssen-Cilag February 2009 - November 2009
Janssen-Cilag December 2005 - February 2009
Purna Pharmaceuticals December 2002 - November 2005
GlaxoSmithKline April 2002 - November 2002
Skills
Life Sciences, Pharmaceutical Industry, People Management, Teamwork, GCP, SOP, Quality, Collaborative Problem..., Quality Systems, Drug Development, Vaccines, Biopharmaceuticals, CRO, 21 CFR Part 11, Quality System, GxP, Regulatory Submissions, Sop, GDP, Quality Assurance, CAPA, Qualified Person..., Clinical Development, Group Presentations, Management, Regulatory Affairs, Oncology, Technology Transfer, Qualified Person GMP..., Pharmacovigilance, Compliance Procedures, Compliance, Biotechnology, Document Management, Public Speaking, Validation, Clinical Research, Auditing, Lifesciences, cGMP, GMP, Pharmaceuticals, Pharmacists, Quality Auditing, Process Validation, Regulatory Requirements, Data Privacy, Records Management, Quality Management, Change Control