Covance

  • Global Regulatory Intelligence Specialist

    Job Location(s) UK-Maidenhead
    Job Number
    2018-24027
    Job Category
    Regulatory
    Position Type
    Full-Time
  • Job Overview

    The Drug Device Safety Solutions & Adjudication group is seeking a Global Regulatory Intelligence Specialist to join their team in either Maidenhead or Edinburgh. In this position, you will collect global regulatory requirements and coordinate maintenance of the global repository. Additional responsibilities include:

    • Maintain thorough understanding of the safety submissions requirements and processes for global regulatory authorities, ethics committees, and investigators 
    • Constantly monitor relevant sources of regulatory requirements
    • Identify applicable documents that require attention for assessment and provide strategic recommendations for active participation to new and revised draft requirements, for comments to draft requirements, or for implementation
    • Communicate strategic recommendations and participate in decision about applicability, owner of actions, implementation plan
    • Execute decision, as applicable, and communicate and train on regulatory requirements
    • Improve the data collection and review process for regulatory filings, surveys, analysis, and reporting
    • Support development of departmental tools and processes and SOPs in accordance with the regulatory requirements
    • Act as SME for the safety reporting submission processes and systems
    • Support internal, external, and regulatory audits and inspectionsSupport Drug Safety project managers and operational team members with the project deliverables related to regulatory/EC/ site submissions 

    Education / Qualifications

    • Bachelor’s degree preferred; however, a combination of education, training, and experience will be considered

    Experience

    • At least 3 years of experience with safety regulatory processing and regulatory reporting
    • At least 1 year of experience with monitoring and maintenance of regulatory intelligence
    • Thorough understanding of EU reporting requirements is highly preferred
    • Some experience in supporting and attending audits and inspections
    • In-depth understanding of global regulatory requirements including FDA, EMA, CFDA, PMDA, etc.
    • Experience working with cross functional project teams and the ability to understand complex requirements
    • Proven ability to work in a fast paced environment and handle multiple projects simultaneously
    • Strong verbal and written communication skills; proven ability to translate technical documentation into effective regulatory submissions
    • Strong organization skills for systemic monitoring of regulations

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