Avanir Pharmaceuticals - Aliso Viejo, CA since Apr 2012
Associate Director, Regulatory Affairs
Pacira Pharmaceuticals, Inc. - San Diego, CA Oct 2008 - Apr 2012
Director, Regulatory Affairs
Valeant Pharmaceuticals - Aliso Viejo, CA Jun 2005 - Sep 2008
Sr. Manager, Regulatory Affairs
Ligand Pharmaceuticals - San Diego, CA Feb 2004 - Jun 2005
Manager, Regulatory Affairs
Gensia Sicor Pharmaceuticals, Inc. - Irvine, CA 2002 - 2004
Q.A. Compliance Manager
Education:
University of Arizona 1981 - 1984
M.S., Nutritional Sciences
Northern Arizona University 1977 - 1980
Bachelor of Science (B.S.), Dual Major - Chemistry and Biology
Skills:
Laboratory Clinical Trials Medical Writing Cro Hplc Gmp Ectd Clinical Research Regulatory Biotechnology Regulatory Affairs Change Control Validation Medical Devices Regulatory Requirements Pharmacovigilance Drug Discovery Lifesciences V&V Oncology Drug Development Gcp Clinical Development Pharmaceutics Regulatory Submissions Formulation Pharmaceutical Industry Technology Transfer Aseptic Processing Glp Therapeutic Areas Capa Fda Sop 21 Cfr Part 11 Ind Biopharmaceuticals
Strategic Planning Financial Reporting Process Improvement Business Strategy Auditing Management Consulting Operations Management Purchasing Manufacturing Powerpoint Troubleshooting Team Leadership Product Development Program Management Contract Negotiation Coaching Business Planning Risk Management Inventory Management Project Planning Management Marketing Strategy Account Management Forecasting Leadership Financial Analysis Non Profits Nonprofits Community Outreach Policy Leadership Development Grant Writing Program Development Training Fundraising Public Speaking Volunteer Management