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Procera Networks, Inc. Message Board

diletante7 2 posts  |  Last Activity: Oct 28, 2015 11:07 AM Member since: Jun 4, 2013
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  • Almost 90,000 shares traded by 11:00 am

  • I view this job opening posted on their website to be a positive development:

    Manager or Sr. Manager, Regulatory Affairs
    Job Purpose

    This key position leads and manages regulatory submissions, including filing of investigational and marketing applications and handling government interactions. The role involves coordinating, writing, and reviewing documents for regulatory submission purposes, with an emphasis on clinical trial applications. Requires a bachelor's degree in science and at least 7 years of experience in the pharmaceutical Regulatory Affairs field. Requires in-depth familiarity with a variety of the field's concepts, practices, and procedures. Relies on extensive experience and judgment to plan, track, and accomplish goals. Performs a variety of tasks. A wide degree of creativity and flexibility is expected, and good communication and organizational skills are essential.

    Duties and responsibilities

    Manages regulatory submission activities from development / investigational stage through to filing and approval to market
    Leads cross-functional teams and works with external consultants to manage the review and preparation of regulatory submissions
    Writes, edits, and compiles documents in support of Agency meetings (eg, prepares meeting requests and briefing documents)
    Reviews and edits various regulatory reports and documentation to ensure regulatory compliance (such as those from quality, preclinical, and clinical disciplines) for submission in INDs, NDAs and other applications
    Participates in development and execution of regulatory strategy for projects
    Monitors impact of changing regulations on submission requirements and updates internal stakeholders
    Leads or assists with other projects and activities as assigned by management in support of the Regulatory Affairs function

11.500.00(0.00%)Jun 4 3:59 PMEDT