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regulatory expert.

职位概述

职位概览

    职位概述

    about the company.
    The company is a Healthcare as a Service (HaaS) enterprise, an integrated medical and healthcare platform, for public health and patients. 
    about the job.

    • Organize China NDA submission including CTD preparation by coordinating project team
    • Lead, establish and maintain communication with CDE and other authorities for consultations, NDAs and Re-Evaluation
    • Support global submissions, such as INDs, NDAs including organizing submission and review process, preparing regulatory sections, reviewing for completeness, accuracy and appropriateness of documentation, and compiling dossier
    • Coordinate communication with CROs and consultants for appropriate regulatory decisions
    • Interpret and advice regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance
    • Offer leadership on project teams with regard to regulatory issues
    • Support and assist with development of regulatory strategy for China approval

    skills and experience required.

     

    • BS/BA or in scientific field required or relevant experience  or master degree
    • Minimum 3 years of experience for master and 5 years of experience for bachelor
    • Good verbal, and interpersonal communication skills and strong attention to detail in English and/or Japanese
    • Excellent understanding of pharmaceutical laws and relevant regulations in China
    • Good understanding of clinical trials and clinical strategy
    • Good understanding of global regulations such as ICH, and relevant regulations in China as needed
    • Proficient in the use of common Microsoft software programs and document management systems
    • Advanced degree in life science or other relevant discipline
    • Good project management and organizational skills; ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment
    • Ability to work on multiple projects
    • Self-starter and problem solver
    • Meet established timelines
    • Technical writing preferred
    • Ability to work well in a team environment
    • Excellent communication skill in English

    about the company.
    The company is a Healthcare as a Service (HaaS) enterprise, an integrated medical and healthcare platform, for public health and patients. 
    about the job.

    • Organize China NDA submission including CTD preparation by coordinating project team
    • Lead, establish and maintain communication with CDE and other authorities for consultations, NDAs and Re-Evaluation
    • Support global submissions, such as INDs, NDAs including organizing submission and review process, preparing regulatory sections, reviewing for completeness, accuracy and appropriateness of documentation, and compiling dossier
    • Coordinate communication with CROs and consultants for appropriate regulatory decisions
    • Interpret and advice regarding regulations, key issues, risks and any other critical topics to interdisciplinary teams and other groups within and outside the organization in order to maximize the business benefit and maintain regulatory compliance
    • Offer leadership on project teams with regard to regulatory issues
    • Support and assist with development of regulatory strategy for China approval

    skills and experience required.

     

    • BS/BA or in scientific field required or relevant experience  or master degree
    • Minimum 3 years of experience for master and 5 years of experience for bachelor
    • Good verbal, and interpersonal communication skills and strong attention to detail in English and/or Japanese
    • Excellent understanding of pharmaceutical laws and relevant regulations in China
    • Good understanding of clinical trials and clinical strategy
    • Good understanding of global regulations such as ICH, and relevant regulations in China as needed
    • Proficient in the use of common Microsoft software programs and document management systems
    • Advanced degree in life science or other relevant discipline
    • Good project management and organizational skills; ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment
    • Ability to work on multiple projects
    • Self-starter and problem solver
    • Meet established timelines
    • Technical writing preferred
    • Ability to work well in a team environment
    • Excellent communication skill in English