Jazz Pharmaceuticals

  • Senior Associate EU/ROW Regulatory Strategy

    Job Post Information* : Posted Date 3 days ago(4/17/2018 3:31 AM)
    ID
    2018-3528
    # of Openings
    1
    Category
    Research & Development
  • Overview

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


    Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


    We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

    Position Profile

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs.  Our focus is on CNS/sleep, hematology/oncology and other areas in which our unique approach may be able to address significant treatment gaps.  The Senior Associate, EU/RoW Regulatory Strategy will be responsible for supporting registration and regulatory activities of commercial and development projects in EU/RoW. 

    Essential Functions

    • Support the preparation, review and submission of regulatory submissions as appropriate by interfacing with local affiliates to manage submissions appropriately (including marketing applications, clinical trial applications, amendments, variations, responses to Agency questions, meeting requests, briefing packages, periodic safety reports)
    • Review and interpret recent product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support development of regulatory strategies
    • Assist in providing risk assessments and recommendations for various regulatory scenarios
    • Participate in the electronic review and quality verification of regulatory submissions
    • Researching and consolidating global regulatory requirements to enable future development of global regulatory strategies
    • Participate in global regulatory team meetings and advise the regulatory team on applicable regulatory requirements and project specific regulatory issues as assigned.
    • Participate in global regulatory team meetings and advise the regulatory team on applicable regulatory requirements and project specific regulatory issues as assigned.
    • Participate in global regulatory team meetings and advise the regulatory team on applicable regulatory requirements and project specific regulatory issues as assigned.
    • Additional duties as assigned

    Required Knowledge, Skills, and Abilities

    • Proven experience working in a Regulatory Affairs department, prior experience in relevant therapeutic area strongly preferred 
    • Experience with eCTD format
    • Experience with preparation and maintenance of regulatory documents
    • Ability to manage timelines in a project team with guidance.
    • Demonstrated problem solving and multi-tasking skills.
    • Excellent attention to detail.
    • Strong planning and communication skills (written and verbal).
    • Ability to manage multiple products in a fast-paced environment.
    • Ability to define problems, collect data, establish facts, and draw valid conclusions
    • Strong English language written and verbal communication skills; additional languages a plus
    • Basic understanding of regulations and guidelines for drug or biologics development
    • Ability to work independently
    • Experience with electronic submissions (eCTD) desirable

    Required/Preferred Education and Licenses

    • Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred

    Jazz Pharmaceuticals is an Equal Opportunity Employer.

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