Brian W.
Associate Director, Regulatory Affairs Strategy @Tanabe Pharma America
New York, NY, US
EMAILS
MOBILE NUMBERS
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WORK HISTORY
Jul 2024 — Present
Associate Director, Regulatory Affairs Strategy @Tanabe Pharma America
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EDUCATION
1990 — 1993
Penn State University
MS, Chemistry
1986 — 1990
Stony Brook University
BS, Chemistry
SKILLS
DocumentumPublishingCpComputer System ValidationDocument ManagementEma21 Cfr Part 11Drug DevelopmentGcpU.s. Food and Drug Administration (Fda)NeesElectronic Common Technical Document (Ectd)Clinical TrialsDcmMedical DevicesPharmacovigilanceGmpValidationCsc Xpress/PublisherNdaMaaDcpPharmaceutical IndustrySopFdaEtmfMrpElectronic SubmissionsLife SciencesCROU.s. Title 21 Cfr Part 11 RegulationChange ControlStandard Operating Procedure (Sop)EctdRegulatory RequirementsIndDocument Lifecycle ManagementRegulatory AffairsLifesciencesCmc
ABOUT BRIAN W.
Regulatory Strategy and Operations professional with experience working in small, medium and large multi-national pharmaceutical companies. Ability to lead the global development of regulatory strategies for rare disease and oncology early and late-stage development project teams. Extensive knowledge of submission publishing and document management systems, including eCTD, NeeS and Documentum. Demonstrated ability to lead geographically dispersed teams.
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