• Overview

    Chimerix is seeking a Director, Regulatory CMC to provide strategic guidance on global regulatory CMC activities.  The selected individual will have significant experience in creating regulatory strategy, reviewing and approving CMC modules, and providing insight to project team in order to ensure compliance with regulatory requirements.

    Roles and Responsibilities

    • As a member of the project teams, provide strategic guidance on FDA and global regulatory requirements for CMC development and registration.
    • Compile, review and approve CMC modules of development and marketing registration applications, amendments, and supplements for submission.
    • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
    • Serve as CMC regulatory lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
    • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
    • Collaborate with contract staff and vendors as needed to support regulatory activities.
    • Provide creative and innovative solutions while being an advocate for compliance.

    Qualifications

    • 10+ years of hands on experience in Regulatory CMC.
    • Bachelor of Science in a scientific discipline required (Chemistry, Biochemistry, or related pharmaceutical science), advanced degree preferred.
    • Ability to train and mentor more junior staff.
    • Established working knowledge of regulatory guidelines and regulations (US and international).
    • Regulatory experience supporting both development projects and marketed products.
    • Strong knowledge of eCTD elements and structure and regulatory writing skills.
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication and presentation skills.
    • Must thrive working in a fast-paced environment while remaining flexible, proactive, resourceful and efficient.

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