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    Regulatory Specialist II - Fremont, United States - Ardelyx

    Ardelyx
    Ardelyx Fremont, United States

    3 weeks ago

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    Description

    Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA(tenapanor) and XPHOZAH (tenapanor), as well as early-stage pipeline candidates. Purpose of the role:

    We are currently seeking a highly motivated Regulatory Affairs Specialist to join our Regulatory Affairs department. Qualified individuals will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Position Responsibilities:
    • Assist with the collection, coordination, and preparation of information for regulatory submission to regulatory agencies and business partners
    • Support the preparation of IND, NDA and international submissions including original marketing applications, clinical trial applications, amendments, supplements, variations responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports, DSURs and labeling review
    • Assist with the maintenance of regulatory files and database so as to establish and maintain in organized manner. Assist with revisions to regulatory documentation thus aiding in timely submissions
    • Assist in coordinating with internal functional groups/project teams to provide input on regulatory matters in accordance with FDA and international regulations
    • Obtain and develop regulatory knowledge; and, with guidance and review by the supervisor distribute regulatory changes/new regulations to appropriate functional groups/project teams that may impact company procedures and/or drug development candidates
    • Participate on project teams as determined by supervisor
    • Participate in management of eCTD publication review of submissions
    • Other related duties as assigned
    Position Requirements
    • Minimum Bachelor's degree in scientific discipline
    • 2+ years experience in the pharmaceutical/bio-tech industry. Awareness of the FDA regulations
    • Good computer skills: proficient in Veeva and Window based software to include Excel and Word.
    • Excellent organizational, verbal, and written communication skills. Attention to detail required.
    • Excellent team player
    • Able to deal with sensitive information with discretion and confidentiality
    • Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and sense of urgency
    This position will be based out of our Fremont, CA office and will be hybrid. The anticipated annualized base pay range for this full-time position is $79,028 - $96,590. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements. Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. Ardelyx is an equal opportunity employer.
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