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QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES



Robert I. Outwater
Regulatory Affairs &
Health Care Compliance

OraPharma, Inc (a Johnson & Johnson company)-Vice President Regulatory Affairs, Board Member, Health Care Compliance (HCC) Officer-multiple international drug approvals and development of firm's HCC program

Hurley Consulting Associates, Ltd.-Vice President Operations-Senior regulatory advisor for multiple US and international clients and senior member of management team

Ohmeda Pharmaceutical Products Division Inc.-Senior Director Worldwide Regulatory Affairs-Directed all regulatory matters and established new international office and new CMC functions

Pharmaceuticals Division, CIBA-GEIGY Corporation-Director Cardiovascular Regulatory Affairs- Responsible for US portfolio of all investigational and marketed cardiovascular products including successful development and approval of multiple drugs (eg. Lotensin)-Other positions held at CIBA-GEIGY: Scientist in pharmacology and regulatory positions of increasing responsibility

Academic Achievements

Psychology- B.A. Fairlegh Dickinson University