Highly focused consulting group consummated to provide strategic and operational guidance on new product development from lead identification through life-cycle management decision gates and post-registration support.Strategic regulatory direction on development and board of health registration requirementsHigh level project management and operational program implementation with decision gate metricsIND, NDA, BLA submission preparation, review, and associated board of health meeting organization/conductBiosimilar and generic program development, biomarker qualification

REsponsible for insight and strategic direction of all regulatory and quality funcitions as a member of the corporate executive management team.Mentored a young pharmaceutical company staff through strategies for drug development process and registration needs. Established relevant policies and procedures consistent with global regulations.Served on Cytochroma/Mitsubishi Tanabe Joint Development CommitteeNegotiated with FDA, moving company's flagship product from full clinical hold to resumption of clinical trials.

Responsible for the strategic coordination of regulatory support for both branded and generic programs. Served on both the Strategy and Operations Committees in support of strategic company direction and implementation of corporate goals. Provided leadership in regisration strategies for development programs to reach earliest possible approvalInstituted policies, procedures and implementation plan for a corporate-wide electronic document management system and regulatory desktop publishing system converting from paper to electronic submission capability.