Deep knowledge of the Global Pharmaceutical Regulatory environment acquired over 21 years' experience, leading business process design and re-design, continuous improvement, delivering and writing training, aligning expectations to achieve process efficiency and drive accountability.Experience in previous role included the on-boarding of colleagues in Shanghai and India; acted as liaison lead with the local samples warehouse; working with senior management across different lines to setup Communication Agreements to effectively process certification and samples in support of international filings and assisting with the development of a new tracking tool for the group. I have previous experience of handling a wide variety of submission types through full lifecycle including CTA, MAA and IRD filings. Key Achievements: -o Led multiple continuous improvement projects and processes, to meet business targets and deliverables, collaborating with the translations vendor and business groups to ensure business needs were met.o Established in-country legalisation process, partnered with legalisation vendor and sourcing countrieso Initiating partnership with key sourcing countries to review and amend process, improving the average Certificate of Pharmaceutical Product processing timelines by 64% (2014 vs 2013 data), enabling earlier submissions and approvalso Successfully introduced process changes to improve consistency and streamline document methodologies, creating system updates & producing staff training guides for rollout, resulting in reduced EMA administration that reduced EMA fees by €24,000 per annum. Pfizer Impact Awards: -o Leading communication framework for COVID-19 across IM, Digital and Business.o Leading the WRS-Agile project and resulting in shorter timelines for submission to Health Authority.o Key contribution to process changes, resulting significant cost savings.o Key contribution and support with Apixaban in Emerging Marketed, resulting in achieving set targets ahead of scheduleo Working in Submissions for active response to an external audit query.o Project Management of a highly successful local Learning Day.