Senior Director, Regulatory Operations

19 hours ago

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Ultragenyx

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rare disease • ultra-rare disease

501 - 1000

Description

• Why Join Us? Be a hero for our rare disease patients • 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. • Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx.

Requirements

• Bachelor's degree in life sciences, technology, or a related field. • Over 10 years of professional regulatory operations experience, ideally in a global environment, including a minimum of 5 years in a leadership role. • Engagement, management, and oversight of external service and resource suppliers that support global operations. • Expert knowledge of eCTD/non-eCTD, regulatory compliance, publishing and document management systems (e.g., Veeva Vault RIM, SharePoint, docuBridge). • 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. • Proven success in managing multiple complex global submissions, developing performance metrics, and driving process improvements. • Exceptional communication and interpersonal skills, with the ability to engage and influence stakeholders at all levels. • Excellent analytical and problem-solving abilities, with a keen eye for detail.

Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans