Remote Senior Director, Regulatory 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:

ultra innovative – Tackle rare and dynamic challenges

Ultragenyx is seeking a technically savvy, highly collaborative Senior Director of Submission Operations to join our Global Regulatory Operations (GRO) team within the Global Regulatory Affairs (GRA) function. Reporting into the Vice President of Regulatory Operations, this role demands a fully engaged, results-driven leader that’s dedicated to executing our global regulatory submission strategies while upholding the highest standards of compliance and quality.

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:

• Operational Excellence: Lead the successful execution of compliant, high-quality regulatory submissions and services that align with business priorities. Ensure that all submission activities strictly adhere to regulatory requirements and company standards, driving operational efficiency.
• Regulatory Expertise: Maintain comprehensive expertise in global filing requirements, including FDA, EMA, CA, MHRA and other health authorities. Utilize in-depth knowledge of drug development processes and functional interdependencies to inform and enhance submission dossier support strategies across the business.
• Leadership & Team Management: Champion the Submission Operations team by cultivating a culture of excellence, collaboration, and continuous improvement. Inspire and empower team members to realize their full potential through effective mentorship and professional development initiatives.
• Stakeholder Influence: Build and nurture strong relationships with key stakeholders, effectively communicating submission strategies and garnering support for initiatives. Influence critical decisions by presenting compelling, data-driven insights and strategic recommendations.
• Innovative Problem-Solving: Challenge conventional practices and proactively seek process enhancements. Use innovative thinking to refine end-to-end submission processes, strengthen core capabilities, and elevate overall performance.
• Adaptability in a Fast-Paced Environment: Proven ability to thrive in dynamic settings by effectively managing multiple priorities and overlapping deadlines. Skilled in assessing emerging industry trends and integrating best practices into team operations to enhance efficiency and drive results.

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. #LI-CS1 #LI-Remote

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 [email protected] .

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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 : [email protected] .