Immunomedics, Inc.

  • Manager, Regulatory Operations

    Job Locations US-NJ-Morris Plains
    Posted Date 2 weeks ago(11/27/2018 12:16 PM)
    Job ID
    2018-1373
    # of Openings
    1
    Category
    Other
  • Overview

    Responsible for formatting and publishing electronic documents, and building of regulatory submission deliverables ensuring submissions are of highest quality and delivered on-time.  The position will also archive and track regulatory correspondences, documents and submissions.

    Responsibilities

    • Electronically format, publish electronic documents and builds Regulatory submission deliverables and ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures. Manages submission timelines and content plans.
    • Assists with implementing and maintaining regulatory systems, and identification of regulatory submission process improvements.  Develops and suggests scalable solutions and processes for business process improvements.
    • Provides guidance to project teams on developing submission structure strategies in accordance with FDA and ICH regulations, guidelines, and/or specifications.
    • Develops and maintains Regulatory document processing and Regulatory submission publishing standards and procedures in accordance with all applicable regulatory regulations, guidance, and specifications. Assists with developing standards and procedures related to authoring, review, transmittal, and archiving of electronic regulatory documents and submissions.
    • Identifies and communicates regulatory system enhancement needs or technical issues.
    • Maintains Document Authoring Template Library and Template development.
    • Communicates the need for additional resources to management as needed.

    Qualifications

    • BS preferred + 5-7 years of related experience.
    • Detailed knowledge of applicable FDA, EU and ICH guidelines related to regulatory submissions, clinical trials and marketing applications.
    • Working knowledge of eCTD publishing systems, EDMS technology (Veeva Vault preferred), and authoring tools and templates (StartingPoint preferred)
    • Clear understanding of regulatory submission content and format requirements
    • Independent, ability to multitask, self-motivated, well organized, detail oriented, able to prioritize, works effectively under pressure, and has excellent written and verbal communication skills.

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