Jazz Pharmaceuticals

  • Senior Associate, Regulatory Strategy

    Job Locations US-PA-Philadelphia | US-CA-Palo Alto | US-PA-Philadelphia
    Posted Date 2 months ago(5/9/2018 9:10 AM)
    Job ID
    # of Openings
    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, Regulatory Strategy will support regulatory activities needed to maintain registration of assigned commercial product(s) in the US as well as regulatory activities required for global clinical trials and support for ongoing development activities for assigned product/programs.

    Essential Functions

    • Support the preparation, review and submission of regulatory submissions as appropriate (including marketing applications, clinical trial applications, amendments, responses to Agency questions, meeting requests, briefing packages, periodic safety reports)
    • Assist in managing internal review and submission of regulatory documents
    • 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
    • Participate in global regulatory team meetings and advise the regulatory team on applicable regulatory requirements and project specific regulatory issues as assigned.
    • Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for regulatory submissions
    • Manage timelines to ensure approvals are timely and development objectives are met
    • Additional duties as assigned

    Experience and Education:

    • Minimum 3 years’ experience in Regulatory Affairs, including experience managing regulatory aspects of an IND and global clinical trial activities.  Experience in CNS/sleep or hematology/oncology therapeutic areas preferred
    • BS or BA degree

    Required Knowledge, Skills, and Abilities

    • Experience with eCTD format
    • Strong English language written and verbal communication skills; additional languages a plus
    • Demonstrated understanding of regulations and guidelines for drug or biologics development
    • 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.
    • Ability to manage multiple projects in a fast-paced environment.
    • Ability to define problems, collect data, establish facts, and draw valid conclusions
    • Ability to work independently

    Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.


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