Regulatory Operations Specialist

Ardelyx
life insurance, parental leave, paid holidays, flex time, 401(k)
United States, California, San Francisco
Mar 07, 2025
Description Ardelyx is a publicly traded commercial biopharmaceutical company 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). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. The Regulatory Operations Specialist will be responsible for collection and coordination of regulatory documentation for submission to regulatory and business partners. Responsibilities: Assist in the preparation of eCTD compliant regulatory submissions Manage submission plan calendar and communicate with publishing vendor Provide oversight and support the processing of Ardelyx's Regulatory Information Management (RIM) platform including file transfer, storage, tracking, and archival of Regulatory submission documents. Support the preparation of IND, NDA, and international submissions including original marketing applications, clinical trial applications, advertising and promotional materials, amendments, supplements, variations responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports, PADER/DSURs, and labeling review Provide regulatory publishing support to other submissions (CTA, IMPD) as needed Ensure high quality submission elements in eCTD format in compliance with all applicable regulations and guidance documents Complete critical review and QC of hyperlinking/bookmarking of regulatory documents Apply company style guide formatting/editing requirements to create submission ready documents that are compliant with internal and heath agency requirements Assist with in-house training, according to project team needs. Training includes Veeva RIM, authoring templates, processes and tools critical to compiling all submission types Other related regulatory duties as required Requirements: Bachelor's degree with 2+ years of related experience in publishing/Regulatory Operations and pharmaceutical/bio-tech industry experience. Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional. Experience with ISI Toolbox and Veeva Vault Regulatory systems preferred Basic understanding of the US, EU, and ICH publishing regulations and guidelines Ability to multi-task, pay close attention to detail, and follow projects through to completion Excellent organizational, verbal, and written communication skills Ability to work independently as an individual contributor and in a team environment 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 Work Environment: Corporate office based (in San Francisco Bay area) or hybrid-based position with potential as needed travel to Ardelyx corporate offices. The anticipated annualized base pay range for this full-time position is $105,000-$129,000. 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 of 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.