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Experience Profile

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Pharmaceutical company serving the U.S. market with specialty drugs focused on five therapeutic areas:  Central Nervous System, Cardiovascular, Gastrointestinal, Respiratory and Anti-Infective.
Regulatory Group Reorganization

​Lead design and implementation of a comprehensive redesign of the company's regulatory group.   The organizational structure featured an realignment which matched the FDA's therapeutic areas enabling improved regulatory agency interaction and streamlined drug filings and clinical trials execution..

Regulatory Strategy Development

​Facilitated workshops with former FDA officials, company executives and regulatory affairs team to develop drug strategies that  the market exclusivity of the company's drug portfolio.