• Regulatory Affairs Scientist

    Posting Date 5 months ago(6/6/2018 1:47 PM)
    Requisition ID
    2018-4666
    Job Location(s)
    Pittsburgh PA United States
    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 Affairs Scientist. The Regulatory Affairs Scientist will lead the scientific evaluation and writing of the company’s regulatory submissions, including common technical documents.  This role will also research various scientific and medical topics related to the company’s technology and product lines.

    Responsibilities

    • Developing regulatory strategy for product and product-related submissions including IND/CTA/BLA and RMAT regulatory filings
    • Writing, reviewing, and finalizing CMC components related to company products
    • Working with product development and technical services in a cross functional team to review product lifecycle documentation as generated according to ICH Q9.
    • Lending scientific advice to the planning, undertaking and oversight of product trials and regulatory inspections
    • Assisting in managing the regulatory aspects of projects/products, including major, complex applications submitted to regulatory agencies
    • Ensuring regulatory submissions are complete, accurate, and comply with applicable regulatory requirements
    • Assisting 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
    • Participating in scientific evaluation of company products as it relates to product safety
    • Reviewing documentation from other departments that may affect regulatory submissions
    • Ensuring that any proposed changes to documentation are consistent with applicable regulatory requirements and that they do not affect a regulatory submission or require communication to regulatory authorities
    • Providing interpretive analyses of complex regulatory guidance documents, regulation, or directives that impact products
    • Assisting in reviewing protocols, specifications, batch record, etc. for regulatory impact, when necessary
    • Assisting in production and quality control materials management programs/ risk analyses
    • Maintaining regular and punctual attendance
    • Maintaining company quality and safety standards
    • Exemplifying Cook MyoSite Core Values

    Qualifications

    • At minimum a master’s degree in any life science field and 5+ years of experience in Regulatory Affairs
    • Experience in CTD-Module 3 writing preferred
    • Experience with immunology or pharmacology preferred
    • Leadership abilities and team orientation
    • Stellar communication skills, both written and oral
    • Understanding of regulations and guidelines governing biological product development (particularly clinical), as well as the ability to apply these to overall strategic product development
    • 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
    • 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 setting
    • Requires up to 10% traveling

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