• CMC Consultant

    Job Locations US-NJ-Jersey City
    ID
    2018-1243
    # of Openings
    1
    Category
    Regulatory Affairs
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    MTDA is rapidly expanding our operation across all functional areas to assist in the research and development of new products for the U.S. market.

    The CMC (Chemistry, Manufacturing and Controls) Consultant will support implementation of MTDA local and global CMC strategies.  He/she will provide support for cross-functional collaborations to integrate CMC programs for MTDA investigational products. The incumbent is also responsible for leading aspects of CMC regulatory submissions and will serve as an internal representative/contact for CMC activities.

    Responsibilities

    Duties:

     

    • Contributes to development of programs/processes that support development of Investigational or New Drug Applications.
    • Collaborates with CMC counterparts in Japan and other departments to execute CMC submission activities, including meeting requests and briefing documents, for INDs/NDAs submitted to regulatory agencies.
    • Executes the timely preparation, review and submission of high-quality CMC content for MTDA submissions of all types and their amendments and supplements as assigned.
    • Lends functional expertise and supports CMC related discussions, negotiations and responses with FDA and internal stakeholders such as Production Technology, Quality Operations, Commercial manufacturing, Supply chain, etc.
    • Interfaces with technical, and regulatory in Japan, as required, on CMC related projects and issues.
    • Support global CMC process development and improvement as required.
    • Provides ongoing lifecycle support for marketed commercial products. 
    • Evaluates and contributes to the outsourcing of manufacturing efforts and change controls, the assessment of regulatory impacts, and provides support for their implementation.
    • Represents Regulatory Affairs CMC function, as required, at various cross-functional team meetings and working group meetings, providing solutions when possible to the project teams on CMC related problems. Escalates more complex issues to the Sr. Director, CMC.
    • Maintains up-to-date knowledge of relevant FDA and ICH requirements relating to CMC activities.
    • Advises and updates teams on the impact of new legislation, regulations and guidance on development plans and registration strategy as it relates to CMC sections for INDs/NDAs.

    Qualifications

    • Minimum B.S. in Pharmacy, Chemistry, Chemical Engineering or related field
    • Advanced degree (M.S. or Ph.D.) is preferred
    • Minimum 5-8 years of experience in CMC activities including submissions to regulatory agencies, interaction with regulatory authorities, and CMC module development and review experience
    • Strong knowledge of pharmaceutical development of drug substance and drug product
    • Knowledge of FDA and ICH regulations/guidance as it applies to CMC/Quality
    • Project management abilities
    • Experience working in a multi-cultural, multi-lingual environment, Japanese company experience is preferred but not required
    • Demonstrated ability to contribute successfully in a multi-disciplinary team environment / matrix organization
    • Working knowledge of DP and API GMP is preferred
    • Competency in MS Office, MS Project
    • Willingness to travel domestically up to 10%

     

    Our Value Proposition:

     

    Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. 

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