Position:
Director, Regulatory Affairs at Ockham Oncology
Location:
Chapel Hill, North Carolina
Work:
Ockham Oncology
- Cary, NC -
Director, Regulatory Affairs
Tranzyme Pharma
- Durham, NC 2012 - 2013
-
Senior Director, Regulatory Affairs
BioDelivery Sciences International
- Raleigh, NC 2007 - 2011
-
Vice President, Regulatory Affairs
Adherex Technologies
- Durham, NC 2004 - 2007
-
Director, Regulatory Affairs
EMD Pharmaceuticals / Merck KGaA
- Durham, NC 2002 - 2004
-
Associate Director, Regulatory Affairs
Glaxo Wellcome / GlaxoSmithKline
- Durham, NC 1998 - 2002
-
Project Director, Regulatory Affairs
NJC Enterprises / Pharmakopius International
- Durham, NC 1994 - 1998
-
Manager, Regulatory Affairs
Education:
North Carolina State University 1992 - 1994
PhD, Toxicology and Cell Biology
University of North Carolina at Chapel Hill 1989 - 1992
MSc, Toxicology
University of Waterloo 1984 - 1988
BSc, Honours Applied Chemistry
Skills:
Regulatory Submissions, Regulatory Affairs, Regulatory Strategy, Drug Development, Clinical Development, Nonclinical Development, Toxicology, Chemistry, Oncology, eCTD, IND, CTA, NDA, MAA, REMS, Pharmaceutical Industry, Biotechnology Industry, Life Sciences, CRO, Protocol
Certifications:
Regulatory Affairs Certified (RAC), Regulatory Affairs Professionals Society