Work:
Otonomy, Inc
Vp, Regulatory Affairs and Qa
Sonexa
Jul 2008 - Aug 2013
Senior Vp, Regulatory Affairs and Quality Assurance
Neurocrine Biosciences
Oct 2000 - Feb 2008
Vice President, Regulatory Affairs and Qa
Iqvia
May 1993 - Oct 2000
Manager To Executive Director, Regulatory and Technical Services
Ciba-Geigy
Oct 1988 - May 1993
Manager To Associate Director, Regulatory Affairs
Education:
College of Saint Elizabeth 1974 - 1978
Bachelors, Bachelor of Science, Chemistry
Skills:
Fda, Drug Development, Regulatory Affairs, Gcp, Gmp, Pharmaceutical Industry, Oncology, Biotechnology, Glp, Clinical Trials, Clinical Research, Clinical Development, Medical Writing, Regulatory Submissions, Quality Assurance, Biopharmaceuticals, Cro, 21 Cfr Part 11, Drug Discovery, Ind, Strategy, Medical Devices, Lifesciences, Pharmacology, Therapeutic Areas, Clinical Data Management, Neurology, Sop, Regulatory Requirements, Edc, Medical Affairs, Diabetes, Clinical Operations, R&D, Chemistry, Medicinal Chemistry, Dermatology