30 years of experience in drug development across a diverse range of therapeutic areas and product types.
Global Regulatory Affairs, Oncology and Infection, Neuroscience, Drug Development, Seasoned Executive, Strategic Thinking, Internal Change Management.
Vice President, Regulatory Affairs, Oncology and Infection, AstraZeneca
Led the global regulatory function supporting oncology and infection therapeutic area, including development and marketed programs. Achieved approvals for IRESSA in EU and CAPRELSA in the US/EU as well as external partnerships including the acquisition of Novexel and licensing of ZINFORO from Forest and approval of ZINFORO in EU. Led regulatory contribution to personalized healthcare and biomarkers, guiding the development of global capability and reviewing project strategies across multiple therapeutic areas. Member of Therapeutic Area Leadership Teams for Oncology and Infection, Regulatory Affairs Global Leadership Team, Forest/AstraZeneca Joint Development Committee, and the Critical Path to TB Regimens (CPTR) Steering Committee and working groups. Represented the company at external meetings with regulators, license partners, trade associations, and other stakeholders. Presented at DIA meetings and lectured on TOPRA MSc Regulatory Affairs.
Global Regulatory Therapeutic Area Head, Neurosciences, Pfizer Global Research and Development
Led the global regulatory contribution to Pfizer’s Neurosciences Therapeutic Area through membership on key governance and technical teams at a portfolio level: Technical Review Committee, Commercial Leadership Team, and Licensing Leadership Team. Contributed to development and implementation of therapeutic and disease area strategies as part of Neurosciences Leadership Team. Managed regulatory strategists assigned to disease areas, development candidates, and marketed products. Directed key regulatory interactions, including participation in regulatory meetings, for product development and marketing: GEODON, LYRICA, CHAMPIX, and ARICEPT. Represented Pfizer at external meetings with regulators, license partners, and other stakeholders. Responsible for developing collaborative working relationships with regulatory authorities and influencing emerging regulatory/policies.
Executive Director, Global Head Regulatory Policy/Intelligence, Pfizer Global Research and Development
Led the Regulatory Policy and Intelligence team based at US and European sites in establishing and managing regulatory policy issues. Member of the leadership team of Worldwide Regulatory Affairs and Quality Assurance. Represented Pfizer regulatory policy to external clients/customers and internal partners.
Executive Director, Worldwide Regulatory Affairs, Pfizer Global Research and Development
Led the regulatory contribution to the exploratory development portfolio of Sandwich Laboratories through coaching team members and membership of the Exploratory Development Management Team (EDMT).
Provided strategic support to global development and regulatory teams across several therapeutic areas.
Led the EU regulatory approval for EXUBERA (Inhaled Insulin), including contributing expertise to the development team, coaching regulatory team members, and managing interface with EU regulators.
Contributed to external regulatory policy initiatives through attendance and presentations at external meetings and discussion with regulators.