• Associate Director, Regulatory Affairs

    Job Locations US-MA-Watertown
    Posted Date 1 month ago(6/19/2018 2:27 PM)
    Job ID
    2018-1100
    # of Openings
    1
    Category
    Regulatory Affairs
  • Overview

    Responsible for the preparation and implementation of regulatory strategies to facilitate the development and approval of new drugs. Prepares U.S. and international submissions and provides support for regulatory approvals.  Responsibilities include communication and coordination with project team members from all disciplines. Support communication and management of regulatory consultants, CROs, and other vendors, as necessary. 

    Responsibilities

    • Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements
    • Manage preparation of meeting requests and briefing documents
    • Author/edit documents to support regulatory submissions
    • Generate/manage trackers and maintain current lists of project specific activities
    • Interact with other departments, especially CMC, to develop regulatory strategy and submission plans for timely filings
    • Participate in regulatory agency inspection readiness
    • Responsible for review of labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
    • Prepare/manage submissions of advertising and promotional materials to FDA OPDP and other HA as needed.
    • Assist with SOP generation
    • Perform other duties as required, interfacing with other departments, CROs and external vendors as needed

    Tetraphase Pharmaceuticals is an Equal Opportunity Employer/Females/Minorities/Veterans/Disability

    Qualifications

    • Knowledge and understanding of global regulatory requirements and guidelines
    • Excellent communication, interpersonal, and organizational skills
    • Knowledge of the Code of Federal Regulations and FDA, EMA and ICH guidelines
    • Knowledge of CTD
    • Knowledge/experience with FDA submission requirements for Investigational New Drug Applications (IND), New Drug Applications (NDA), and Drug Master Files (DMF)
    • NDA preparation management and submission experience desirable

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