• Associate Director, U.S. Regulatory Affairs

    Job Locations US-IL-Bannockburn
    Posted Date 2 weeks ago(8/1/2018 11:10 AM)
    Job ID
    2018-2403
    # of Openings
    1
    Category
    Regulatory
  • Overview

    Ready to join a team committed to moving gene therapies into the clinical and commercial settings for patients and families devastated by rare neurological genetic diseases? AveXis is advancing cutting-edge science to treat rare and life-threatening genetic diseases starting with our clinical-stage, proprietary gene therapy candidate, AVXS-101. We are in the midst of an incredible journey, and are looking for passionate individuals to join us on this important mission.

     

    AveXis, Inc., a Novartis Company, is a clinical-stage gene therapy company, dedicated to developing and commercializing novel treatments for patients suffering from rare and life-threatening neurological genetic diseases. Our initial product candidate, AVXS-101, is our proprietary gene therapy product candidate currently in development for the treatment of spinal muscular atrophy, or SMA, Type 1, the leading genetic cause of infant mortality, and for the treatment of SMA Type 2. The U.S. Food and Drug Administration, or FDA, has granted AVXS-101 Orphan Drug Designation for the treatment of all types of SMA and Breakthrough Therapy Designation, as well as Fast Track Designation for the treatment of SMA Type 1. In addition to developing AVXS-101 to treat SMA Type 1 and Type 2, we also plan to develop other novel treatments for rare neurological diseases, including Rett syndrome (RTT) and a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene.

     

    Lead clinical Regulatory representative on one or more gene therapy programs. Oversight of one or more support staff.  Accountable for relationship and communication with cross functional teams.  Oversight of RA filings required for clinical trials through to submission of marketing authorization applications.

    Responsibilities

    • Accountable for regulatory strategy and vision across one or more gene therapy programs.
    • Accountable for alignment of regulatory strategy to business.
    • Ensure alignment across the regulatory function (CMC, nonclinical, clinical, and commercial).
    • Development and negotiate overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations.
    • Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements.
    • Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

    Qualifications

    • Bachelor’s degree required, MPH or graduate level degree preferred.
    • At least 8 years of experience with increasing responsibility in the pharmaceutical industry.
    • Sound basis of Scientific (Training/Communications) knowledge.
    • Broad experience across multiple functional areas desired.
    • Expert knowledge of regulations, current industry practices, and strong experience with interpretation and application.
    • Excellent written and verbal communication, presentation, and facilitation skills.
    • Expert risk management skills.
    • Experience with rare diseases preferred.
    • Experience with breakthrough therapy products preferred.

     

    The level of this position will be based on the final candidate’s qualifications.

     

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 

     

    AveXis is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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