Acted as the global strategic regulatory partner responsible for innovating, expanding, maintaining and optimizing Sanofi's Established Products and Global Health portfolio of 500+ INNs within the China and Emerging Markets global business unit.

Portfolio lead for Endocrinology and Lysosomal Storage Disorders Rare Disease areas with the responsibility for ensuring regulatory resources and deliverables (global development and registration strategies, submissions/approvals, lifecycle initiatives, etc.) are in place and executed in accordance with regulatory and quality expectations.

Member of the Accelerated R&D Senior Leadership Team Primary responsibility was to support the growth and strategic oversight for Accenture's global regulatory offerings including Accenture’s Regulatory capabilities and go-to-market strategy. Initiated and executed an appropriate strategic alliance strategy that provided efficient and best-in-class services to complement existing capability. Represented regulatory at client meetings, bid defense, strategic workshops and industry conferences. Contributed to the regulatory strategies for client’s programs for investigational and marketed product applications.

Held the following positions within the Regulatory Affairs group: Manager, Regulatory Affairs (January 2004 – June 2005) and Team Leader, Regulatory Affairs (September 2002 – December 2003). Key responsibilities included reviewing and approving ANDAs and post-approval CMC submissions to regulatory authorities as well as interacting with other applicable departments to discuss and provide solutions to regulatory issues, problems and/or strategy. In September 2004 – December 2004, I served as Acting Director responsible for managing all departmental activities, including but not limited to project assignments, change control, department budget, as well as represented Regulatory Affairs for product selection team and production optimization committee. Additionally, I provided the leadership, development and performance management of 4 Regulatory staff.

Held the following positions within the Regulatory Affairs group: Supervisor Regulatory Affairs (January 2002 – August 2002), Senior Regulatory Scientist (May 2000 – December 2001), Regulatory Scientist (May 1999 – April 2000), Senior Document Specialist (June 1998 – May 1999). Key responsibilities included coordinating, compiling and reviewing data for submissions to the FDA in support of 505(B)(2) NDAs, ANDAs, Amendments, Supplements and Annual Reports as well as reviewed and approved Qualification, Requalification and Concurrent Validation reports for terminal sterilizers, lyophilizers and filling lines. Additionally, I supervised a team of 4 Regulatory Scientists, including the assignment of work as well as performance appraisals.

Responsible for compiling data for submissions to the FDA in support of ANDAs, Amendments, Supplements and Annual Reports. Additionally, coordinated in-house and private customer product label approvals and performed outside facility audits in order to ensure compliance of cGMP and FDA regulations.