Head Of Regulatory Sciences, Australia New Zealand, And Korea Pfizer Biopharmaceuticals Group
CurrentLead and manage the strategic direction, operation and performance of the Regulatory Affairs Department for the Pfizer Biopharmaceutical Business in Australia and New Zealand. Encompasses all aspects of regulatory affairs, including NCE submission, product Lifecyle work, Clinical Trials support and supply continuity activities. Work closely with commercial/business leads to understand and help manage business environment and accountable to ANZ business and Global Functional lines for overall performance of Department. Work closely with Medical Affairs, Medical Information, Drug Safety, Supply and Quality functions. Represent Pfizer on key Industry Association/Regulator liaison Groups. Responsible for budget to agreed opex/capex targets.Achievements:Successful approval of numerous pipeline and joint venture NCE/LE , with significant outcomes for patients and the business.Regular review of Department effectiveness, cultural strengths and colleague engagement to emphasise/improve support for staff to be successful in their roles. Managed Department and staff through multiple restructure/reorganizations, with high staff engagement, retention levels and focus on delivery of submissions and approvals.Key contributor to significant enterprise wide initiativesCore member of cross functional leadership groups which have contributed to improvement of local work culture.Supported colleagues in moving to remote/home working, with continued focus on connectivity and support.
