Senior Director, Global Regulatory Submission Operations

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. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultradedicated – Your biggest challenges yield rare possibilities Ultragenyx is seeking a strategic, results-driven, and forward-thinking Senior Director to lead Global Submission Operations. This critical leadership role is accountable for the strategy, oversight, and delivery of compliant, timely, and high-quality regulatory submissions that advance Ultragenyx’s rare disease portfolio and global expansion priorities. The ideal candidate brings deep Regulatory Affairs/Operations expertise, hands-on mastery of global submission publishing and document management systems (e.g., Lorenz docuBridge, Veeva Vault RIM), and the ability to translate technical requirements into operational excellence. Exceptional communication, collaboration, and leadership skills are essential to drive cross-functional alignment and elevate submission quality, efficiency, and predictability worldwide.

Work Model:

• Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

Strategy, Leadership & Collaboration Own global Submission Operations strategy and execution—setting operational standards, performance targets, and compliance frameworks aligned with corporate priorities and evolving global Health Authority expectations. Partner with Global Regulatory Affairs and cross-functional teams to drive effective submission planning, ensuring technical accuracy, readiness, and alignment with development and regulatory strategies. Collaborate closely with Regulatory Project Management and Regulatory Information Management & Systems to enable integrated, end-to-end submission execution. Provide senior leadership with clear, insight-driven updates on submission status, risks, readiness, and emerging trends. Identify, anticipate, and mitigate operational, technical, and compliance risks to ensure predictable, right-first-time submission delivery. Scale operations to support new markets, technologies, and regulatory pathways, embedding agility, efficiency, and digital enablement across submission activities. Team Management Lead, mentor, and develop a high-performing global Submission Operations team aligned with Ultragenyx values and performance expectations. Set a clear vision and operating model that empowers employees through accountability, coaching, development, and recognition. Foster a culture of operational excellence, quality, continuous learning, and data-driven decision-making. Champion diversity, equity, and inclusion—ensuring diverse perspectives strengthen operational decisions, innovation, and team effectiveness. Global Submission Operations Oversee all aspects of global electronic and paper submissions, including planning, dossier compilation, technical validation, and dispatch to Health Authorities. Ensure all submissions meet regional and global technical requirements and pass validation without issue. Drive the implementation, optimization, and lifecycle management of publishing, validation, and submission-related technologies in partnership with Regulatory Systems and IT. Maintain operational tools, templates, and procedures that ensure efficiency, consistency, and inspection-ready documentation across submission activities.

Requirements:

Education & Experience

• Bachelor’s degree in Life Sciences, Technology, or related discipline (advanced degree preferred).

10+ years of progressive Regulatory Operations experience within a global biopharmaceutical environment, including 5+ years in senior leadership.

• Deep expertise in global submission publishing, lifecycle management, and document management tools (e.g., Veeva Vault RIM, Lorenz docuBridge).
• Strong understanding of global regulatory frameworks and digital/data dossier standards (FDA, EMA, MHRA, PMDA, ICH, Health Canada).
• Strategy, Leadership & Collaboration
• Demonstrated ability to lead transformation, build operational capabilities, and deliver measurable improvements in quality, efficiency, and predictability.
• Strong executive presence with the ability to influence, align, and inspire across all levels and functions.
• Skilled at synthesizing complex technical, operational, and regulatory information for diverse audiences.
• Proven ability to simplify complexity, lead change, and embed scalable, data-driven processes across global teams.

Systems thinker who integrates people, processes, and technology to drive durable business impact. Team & Talent Management Experience designing and executing talent strategies that strengthen leadership pipeline, build technical competency, and support long-term organizational growth. Demonstrated success managing global teams, navigating cultural and regional differences, and fostering an inclusive, collaborative environment. Proven track record of elevating team performance, engagement, and accountability across dispersed geographies. #LI-CS1 #LI-Remote The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Pay Range $245,600—$303,300 USD

Full Time employees across the globe enjoy a range of benefits, including, but not limited to:

· 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

• Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.