19 hours ago
πΊπΈ United States β Remote
π΅ $234.9k - $290.2k / year
β° Full Time
π Senior
π Compliance
π½ H1B Visa Sponsor
β’ Why Join Us? Be a hero for our rare disease patients β’ At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. β’ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx.
β’ Bachelor's degree in life sciences, technology, or a related field. β’ Over 10 years of professional regulatory operations experience, ideally in a global environment, including a minimum of 5 years in a leadership role. β’ Engagement, management, and oversight of external service and resource suppliers that support global operations. β’ Expert knowledge of eCTD/non-eCTD, regulatory compliance, publishing and document management systems (e.g., Veeva Vault RIM, SharePoint, docuBridge). β’ In-depth understanding of global regulatory requirements (e.g., FDA, EMA, ICH) and emerging health authority initiatives and standards with ability to assess impact, communicate, and update and/or mobilize change, to support business objectives. β’ Proven success in managing multiple complex global submissions, developing performance metrics, and driving process improvements. β’ Exceptional communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels. β’ Excellent analytical and problem-solving abilities, with a keen eye for detail.
β’ Generous vacation time and public holidays observed by the company β’ Volunteer days β’ Long term incentive and Employee stock purchase plans or equivalent offerings β’ Employee wellbeing benefits β’ Fitness reimbursement β’ Tuition sponsoring β’ Professional development plans
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