Experience

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  Muscat pharmaceutical trading

  Jan 2006 - Jan 2009

  Regulatory affairs coordinator
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  Al razi pharmaceutical co.

  Jan 2009 - Jan 2011

  Regulatory affairs manager
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  Roche

  Jan 2011 - Jan 2019

  Oversaw development, implementation, and management of regulatory strategies and submissions to ensure optimal registrations of NDAs, line extensions, and life cycle maintenance applications. Led engagements with industry association and Health Authority to shape regulatory environment. Ensured compliance of products and promotional materials with local, U.S. FDA, and European Medicines Agency (EMA) regulations. Established standard operating procedures and corrective actions and preventive actions (CAPAs). Monitored key performance indicators and managed external vendor oversight plans. Show less

  • Regulatory Affairs Manager & Scientific Office in Charge

    Jan 2014 - Jan 2019

  • Regulatory Affairs Specialist

    Jan 2011 - Jan 2014
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  Astrazeneca

  Jan 2020 - Jan 2022

  Led team of six to develop and implement strategies to achieve regulatory approvals for therapeutic areas of Oncology; Specialty; Respiratory; Cardiovascular, Renal, and Metabolism (CVRM); and rare disease. Directed communications with regulators, distributors, and industry groups.Supervised projects covering safety reporting, serialization (track and trace), integration of new regulatory database, content creation and management, good regulatory practice (GRP), importation clearance with Health Authorities, and local manufacturing planning. Managed creation of advertising and promotional materials used to obtain Health Authorities’ approval across the Gulf. Managed budget and resource allocation. Show less

  • Associate Director, Regulatory Affairs Gulf & Pakistan

    Jan 2021 - Jan 2022

  • MEA Regulatory Lead, Covid-19 Vaccine Project

    Jan 2020 - Jan 2022

  • Regulatory Affairs Senior Manager, Gulf & Pakistan

    Jan 2020 - Jan 2021