• Regulatory Operations Specialist

    Posting Date 3 weeks ago(7/26/2018 5:31 PM)
    Requisition ID
    2018-4967
    Job Location(s)
    Pittsburgh PA United States
    Travel
    None
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Regulatory Affairs
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Regulatory Operations Specialist.  The Regulatory Operations Specialist will assist in the preparation and review of submissions to regulatory authorities for all necessary activities.  This role will also ensure that all aspects of the Quality System that directly affect such submissions, such as materials management, comply with the regulations of all applicable governing bodies.

    Responsibilities

    • Assist in managing the regulatory aspects of projects/products, including major, complex applications submitted to regulatory agencies
    • Assist in preparing clinical documents for regulatory submissions, including clinical study reports, clinical protocols, investigator’s brochures, and safety and efficacy summaries
    • Conduct research on submission requirements and options
    • Ensure regulatory submissions (for IND, IMPD, BLA, NDA and/or PMA) are complete, properly formatted, and comply with applicable regulatory requirements for publishing
    • Assist in setting up direct interactions with governmental agencies and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications
    • Plan and assist with formal meetings, teleconferences with regulatory authorities, and requests for information
    • Maintain a centralized archive of all local regulatory files and chronology indexes and assure compliance of regulatory files
    • Create and/or maintain submission authoring templates
    • Participate in the writing and reviewing of Regulatory processes (SOP, Work Instructions and internal guidelines)
    • Assist in the review of advertising and promotional items
    • Responsible for the compilation of routine eCTD submissions for various submission types (e.g. safety reports, investigator information, protocol amendments, etc.) on a daily basis
    • Compile and submit annual report and post-approval supplements for products

    • Maintain schedule of and file post-approval documentation

    • Partner with cross-functional teams within the organization to ensure the regulatory requirements and globally harmonized standards are understood and represented in the quality system

    • Focus on improvement of the technical files review product/manufacturing process changes, supplier changes, and investigator changes

    • Provide interpretive analyses of complex regulatory guidance documents, regulation, or directives that impact regulatory submissions

    • Lead regulatory support team by ensuring a cross function team reviews and responds to surveillance activities

     
     

     

    Qualifications

    • At minimum, an undergraduate degree in any life science, business, engineering or management field
    • Experience with regulatory documentation
    • Understanding of regulations and guidelines governing biological product development (particularly clinical), as well as the ability to apply these to overall strategic product development
    • Leadership ability and team orientation
    • Effective oral and written communication skills
    • Excellent problem-solving skills and ability to work in collaborative and independent work situations with minimal supervision
    • Must work and interact effectively and professionally with others

     

    Physical Requirements:

    • Must be able to sit at desk, in meetings and/or work on a computer

    • Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation

    • Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation

    • Must perform PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (shirt and pants) and appropriate shoes required on occasion

    • Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II

    • Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required

    • Ability to work under specific time constraints
    • Laboratory and office settings
    • Requires up to 10% traveling

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