Richard
Submissions Manager @Pfizer
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WORK HISTORY
Submissions Manager @Pfizer
Drive submission coordination activities for assigned products and/or regulatory procedures as appropriate. Delivering project specific Pfizer electronic and paper regulatory submissions. Co-ordination and execution of publishing solutions that meet unique requirements of each submission and national market, management of product delivery to regulatory agencies and subsequent archival.Maintain a working knowledge of electronic and paper publishing systems and tools and how these are applied; fluency with multiple dossier format and publishing and translation requirements as required.Ongoing liaison with Project Team and country representatives to ensure paper and electronic submission requirements, translation requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery to regional and national markets.Lead/participate on global/local teams to complete assignments and tasks within a specific task force/project associated with electronic and paper submissions.Help interpret regulatory guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.Contribute to effective forecasting and management of project specific resources utilizing flexible resourcing, and global load sharing as normal business practice.Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.Participate in the definition and implementation of national and regional process efficiencies for submission publishing and project learning sessions. Responsibility for training and mentoring fellow colleaguesCurrent focus on Africa and the Middle East with specific responsibility for Saudi Arabia, Egypt and Sudan.Subject Matter Expert for labelling submissions for AfME region.Development of and overseeing implementation of labelling process within AfME region.
EDUCATION
Chatham House Grammar School
A, B, C, D, A-Levels: General Studies, Geography, English Literature, Physical Education
University of Southampton
Bachelor of Arts (B.A.), Geography
ABOUT RICHARD
Execution Hub Team Lead, International Developed Markets, Regulatory International Operations
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