Immunomedics, Inc.

  • Senior Manager, Regulatory Project Management

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(6/19/2019 11:50 AM)
    Job ID
    2019-1464
    # of Openings
    1
    Category
    Regulatory
  • Overview

    Senior Manager, Regulatory Project Management, under direction of the Director of Regulatory Project Management, will work effectively with product development teams to establish and manage timelines and deliverables in support of global regulatory submissions, with a focus on CMC submissions. This individual will coordinate submissions using Veeva Vault RIM, establish submission timelines and track progress for submission deliverables, coordinate/ support cross-functional submission planning meetings, and collaborate closely with Regulatory Operations for submission execution. 

    Responsibilities

    Senior Manager, Regulatory Project Management will play a key role in establishing and tracking timelines and implementing planned regulatory strategies and requirements into practical, workable deliverables to support development and commercial stage drugs.

    • Prepares and manages integrated submission plans to include timelines, deliverables, responsible parties, and other key information as needed; collaborates with cross-functional teams to plan and execute submissions.
    • Tracks regulatory objectives, agency commitments, health authority questions, and submission deliverables in Veeva Vault RIM system.
    • Prepares administrative documents for regulatory submissions (e.g., forms).
    • Tracks the development (authorship and review) of CMC related submissions such as regulatory briefing packages, responses, amendments and supplements.
    • Proactively identifies program issues and implements appropriate strategies to mitigate risks.
    • Maintains current knowledge of regulations regarding submission management, country requirements and guidelines (FDA, EMA, ICH, PMDA and others as required) and instructs the team of changes to process.

    Qualifications

    • BA in Science or related field with 5 to 7 years’ experience in Pharmaceutical Industry
    • Strong organizational and communication skill set.
    • Proven track record of successful on-time submissions.
    • Regulatory knowledge of submission requirements, content and format for submissions to Global health authorities.
    • Common Technical Document (CTD) structure, electronic (eCTD) submission requirements, and electronic document management system (First Doc, Veeva)
    • Regulations, guidance, and procedures applicable to FDA (CDER Division of Oncology, Office of Hematology and Oncology, and Office of Biotechnology Products), and EMA.
    • Microsoft® Office 365 suite, with experience in MS Project and MS OneNote applications
    • Knowledge of Veeva Vault RIM (preferred not required)

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