• Regulatory Post Market Specialist

    Posting Date 1 week ago(12/6/2018 5:35 PM)
    Requisition ID
    2018-5738
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Regulatory Affairs
  • Overview

    The Regulatory Post Marketing Specialist at Cook MyoSite will manage the preparation, review and maintenance of post marketing submissions to health authorities and assure that aspects of marketing, distribution, and labeling functions that directly impact submissions comply with the regulations of all applicable health authorities and additional regulatory authorities as needed.

    Responsibilities

    • Provide strategic labeling, marketing and distribution guidance to the organization including staying up-to date with global guidance and regulations
    • Collect and review development study reports,

    pharmacovigilance data (post-marketing) and any other scientific reports to assess the safety and efficacy of marketed products
    • Collaborate with the cross-functional team to develop and maintain documents of product characteristics and patient leaflet for marketed products within the framework of regulatory submissions to support Marketing Authorizations
    • Manage regulatory requests for information pertaining to labeling, marketing and distribution which implies interface with International Health Agencies
    • Assist in managing the regulatory aspects of projects/products, including major, complex applications submitted to regulatory agencies
    • Manage regulatory label submissions, including: Structured Product Label (SPL) format for FDA, Summary of Product Characteristics (SmPC) format for EU, and additional regional formats
    • Compile and submit annual distribution reports for products sold according to regional market authorizations

    • Provide leadership for and manage regulatory aspects of the copy review / approval process for promotional materials, ensure compliance of promotional materials with global laws, regulations and published guidance documents
    • Contribute to the development and implementation of policies and procedures for regulation of promotional materials and other external communications/press releases, for product label and patient leaflet, and for import/export distribution functions
    • Manage the review, approval and submission of advertising and promotional materials to health authorities. Work closely with the Legal, Clinical Safety, and Global Business units on improving and enhancing the review process, establishing consistent best practices and submission guidelines
    • Provide strategic guidance on import and export requirements through health authorities and additional regulatory authorities to ensure timely transport of tissue and products
    • Plan and assist with formal meetings and teleconferences with health authorities

    Qualifications

    • At minimum a Bachelor's degree in any life science, business, engineering or management field
    • Experience with regulatory documentation
    • Leadership ability
    • Team oriented skills

    • Stellar communication skills
    • Understanding of regulations and guidelines governing biological product development, as well as the ability to apply these to overall market authorizations
    • Must work and interact effectively and professionally with others
    • Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

     

    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

    • 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
    • Office setting
    • Requires up to 10% traveling

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