Immunomedics, Inc.

  • Senior Director, CMC Regulatory Affairs - (China regulatory experience required)

    Job Locations US-NJ-Morris Plains
    Posted Date 2 months ago(7/5/2019 2:47 PM)
    Job ID
    2019-1453
    # of Openings
    1
    Category
    Regulatory
  • Overview

    Director, CMC Regulatory Affairs will translate regulatory requirements working effectively with the respective process and manufacturing teams to collaborate, implement and interact meaningfully into workable strategies and plans for various stages of drug development of drug substance and drug product. This individual develops and implements CMC regulatory strategies to support the conduct of clinical trials and registrations in the US and global markets for the development and commercialization of pipeline drugs in the context of submissions to, and communications with, the Health Authorities while actively contributing as a key member of the project team.

    Responsibilities

    CMC Regulatory Director will play a leading role in translating CMC regulatory requirements into practical, workable strategies and plans for development and commercial stage drugs.

    • Develops CMC regulatory strategies for assigned program(s) in collaboration with cross-functional team and through analysis of guidance, main focus be working with the Asian authorities in China and South Korea
    • Advises on the development and implementation of CMC regulatory strategy through the manufacturing and other processes; specifies potential risks and responds to new government/regulatory developments.
    • Maintains current knowledge of regulations and guidelines (FDA, EMA, ICH, PMDA and others as required) supports the development and authorship of communications such as regulatory briefing packages.
    • Support Good manufacturing practice (GMP) for biologics and combination products and regulatory approval processes
    • Reviews Chemistry, Manufacturing and Controls documents with respect to alignment with program strategy and consistency of scientific interpretations/messages, clarity, completeness, and regulatory requirements.
    • Proactively identifies program issues and implements appropriate regulatory strategies to mitigate risks.

    Qualifications

    • BA in Science with 10 to 15 years of experience in Pharmaceutical Industry
    • Biologics drug substance and drug product manufacturing and quality assurance (QA)/ quality control (QC)
    • Common Technical Document (CTD) structure, electronic (eCTD) submission requirements, and electronic document management system (First Doc, Veeva)
    • Guidance documents related to CMC for International Conference for Harmonization (ICH)
    • Good manufacturing practice (GMP) for biologics and combination products
    • US and EU Biologics, and Device Development (21 CFR Parts 3, 4, and 800) and Approval process
    • Experience and knowledge of drug development regulations in China
    • Regulations, guidance, and procedures applicable to FDA (CDRH and CDER Office of Pharmaceutical Quality, Office of Hematology and Oncology, and Office of Biotechnology Products), and EMA (Biosimilars, European Medical Device Directive).

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