Ultragenyx

• Day-to-day administrative support for the Canadian Vice President & General Manager, and functional leads in Medical Affairs, Market Access, Commercial Operations, Marketing, as well as support for Canadian field teams • Proactively manage calendar, appointments, and meeting requests through MS Outlook • Communicate with Canadian leadership, external partners, and internal stakeholders to schedule and set up in-person and virtual meetings • Participate in special projects and project management work as required by the business • Contract coordination — support contract-related administrative tasks including document preparation, routing for signatures, and maintaining organized contract files • Compliantly manage financial processes including purchase order creation and management, invoice payment, budget management and monitoring, and other necessary processes • Contract creation, review support, lifecycle management, and tracking across internal systems • Monitor contract timelines, ensuring renewals, expirations, and compliance requirements are proactively addressed • Track invoices and honoraria and ensure timely payment • Develop tracking mechanisms in Excel for external expense budgets in alignment with invoices • Ensure adherence to compliance requirements for payment of honoraria and invoices as well as vendor contract management • Manage and access necessary online portals/software (iCertis, Oracle, Veeva, OneDrive, Adaptive, SharePoint, Concur, Zoom, Microsoft Teams, etc.) and others as needed • Conduct regular check-ins with other administrative personnel to optimize activity • Coordinate interviews, onboarding, and hiring processes

• Build and steward authentic relationships based on respect, understanding and advancing patient focused priorities. • Embed patient and caregiver perspective and strategic insights from our communities across business strategy, accelerating existing efforts and identifying new opportunities to meaningfully partner across the medicines lifecycle. • Understand and navigate internal stakeholder engagement, ensuring plans reflect cross functional engagement; facilitating the compliant exchange of complex scientific information related to Ultragenyx areas of research, product development and commercialization. • Partner closely with Government Affairs, Communications and Regulatory to ensure appropriate patient, caregiver and advocacy leader awareness of, and engagement with, regulatory agencies and policymakers on issues of access and reimbursement. • Demonstrate leadership within the Patient Advocacy team, across Ultragenyx, and externally with the goal of fostering a best-in-class patient advocacy function. • Oversee the patient advocacy budget, ensuring company resources are used efficiently and effectively, including the management of external strategic partners.

• Identified as an HEOR subject matter expert, able to provide consultation as an internal HEOR subject matter authority to other departments and responsible for developing HEOR strategy and leadership among cross-functional project teams, to mitigate risk and achieve success, across the portfolio of Ultragenyx programs globally • Generate HEOR data to support clinical development and reimbursement, including design, implementation and analysis of HEOR studies • Proactively collaborates and demonstrates cross-functional leadership across the organization to facilitate alignment around key HEOR endpoints, outcomes and deliverables and partners closely with internal stakeholders, including medical, clinical development, commercial, market access, endpoint development strategy and management team to identify and develop appropriate HEOR strategy to support global development and reimbursement plans across US, Canada, EMEA, LATAM and APAC regions • Identify evidence gaps to inform strategic planning and lead development of new evidence strategies to increase understanding of target patient populations of UGX programs and lead development of new evidence generation strategies to achieve market access across global target patient populations of UGX programs • Review and provide health economics and outcomes research input into clinical development program planning, integrated evidence generation plans, regulatory documents with accuracy and scientific integrity • Provide leadership through influencing without authority across project teams, internally and externally, can identify & lead cross functional teams for external collaborative research partnerships from project inception thru publication(s) and presentation(s) • Represent Ultragenyx as Global HEOR subject matter expert at external professional, scientific meetings and forums

• Provide leadership for the integration of scientific information activities, establishing cohesive program strategies that align the following with core program teams: • Clinical regulatory documents • Clinical trial disclosure and transparency activities • Scientific publications and congress dissemination • Library sciences search and delivery • Ensure continuity and consistency of scientific data interpretation and messaging across development and commercialization stages • Oversee the development and execution of integrated, lifecycle-based publication strategies aligned with Regulatory milestones and Medical Affairs objectives • Ensure publications are strategically sequenced to support launch readiness, scientific leadership, and long-term evidence generation • Partner with authors, investigators, and internal stakeholders to uphold the highest standards of scientific integrity, transparency, and compliance • Provide strategic oversight for clinical trial disclosure and data sharing activities, ensuring alignment with global regulations and evolving transparency expectations

• Partner with Regulatory leads to manage regulatory filing subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities associated with Ultragenyx’s development and post-marketing activities • Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies • Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays • Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines • Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the Ultragenyx portfolio to most effectively support global regulatory pathways • Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are informed and knowledgeable of activities, progress /delays, and risks / issues • Facilitate regulatory filing team and working group meetings (schedule, prepare /distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required) • Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices

• Provides global labeling leadership in support of the development, registration, and life-cycle management of Ultragenyx products for rare diseases. • Prepare new and revised labeling content (Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and other reference sources. • Demonstrate the ability to work in a matrix environment communicating label concepts and key messaging during label development consistent with program strategy and understanding and educating the impact to downstream activities (i.e., for commercial, and promotional educational purposes). • Build strong collaboration with key internal stakeholders, including Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other functions to support development of draft label text. • Interact with the cross functional labeling team (Label Working Group and Label Review Committee) to ensure timely implementation of global labeling changes in local product information that are consistent with the company’s position defined in the CCDS and in compliance with local labeling regulations. • Prepare, deliver and/or manage all types of regulatory documents/submissions influencing and managing cross-functional team member input to provide high quality deliverables that meet regulatory standards, and corporate and program milestones. Facilitate LWG/LRC/SME meetings to develop content for label documents including resolution of complex label issues and ability to drive consensus utilizing current standard operating procedures, best practices and/or work instructions including work requests associated with partner companies and vendors. • Facilitate and lead target label strategies with cross functional labeling team incorporating key messaging aligned with target product profile and thorough understanding of competitive landscape environment. Provide necessary label output for HA interactions (i.e., FDA/EMA/PMDA/HC briefing book, scientific advice, and/or other key submission readiness milestones). • Manage approved labels in a document label management system to ensure accurate and up-to-date labeling is always available and accessible for global submissions and inspection readiness. • Contribute to the review and approval of artwork supporting global submissions. • Implement and maintain a quality control measure during all stages of label development. • Maintain knowledge base of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area(s). • Initiate or contribute to local and/or global process and/or system improvements which have a significant impact on business.

• Serve as a senior external medical leader for Ultragenyx gene therapies, leading compliant complex, scientific discussions with treating physicians • Enable successful implementation of gene therapies globally both within Ultragenyx and with external medical experts • Respond to inquiries and questions from treating sites with appropriate level of urgency • Lead the strategic and scientific requirements for educational materials and lead the delivery of training for the gene therapy treatment centers to ensure those centers are well prepared to manage patients throughout their gene therapy treatment journey • Provide expertise and contribute as needed to protocol development, steering committee meetings, data generation initiatives of Disease Monitoring Programs, and life-cycle management for label/indication expansion • Advise on strategic development of publications and medical materials that enable external medical engagement and address evidence gaps to inform clinical decision making • Work in partnership with VP, GME – Gene Therapies to develop and implement the global Gene Therapies Treatment Team Framework • Mentor and develop Global Medical Expert physicians and MSLs, helping build a scalable, high-performing medical organization to support current and future gene therapy launches • Provide expertise and contribute as needed to key regulatory agency communications, including filings and information request responses • Represent Ultragenyx at key scientific and external stakeholder meetings to advance awareness and deep understanding of our science and therapies • As an expert, lead the education and training of Ultragenyx internal teams • Stay abreast of internal and external developments, trends and dynamics and provide direction for strategic implications to the development and commercialization of gene therapy

• Serve as territory business owner with a focus upon impact and territory analysis. Other key areas of focus include optimizing: i) patient diagnosis and care through HCP education, ii) educating HCPs about Ultragenyx approved products, iii) assisting with treatment fulfillment • Ability to develop and nurture effective business relationship management with key stakeholders, including HCPs, Registered Dieticians, Genetic Counselors, Pharmacists, and related support staff • Proactively builds effective working relationships with internal/external stakeholders; can drive agreement/decisions from multiple stakeholders; ability to understand people’s emotions and flex communication style. Can adjust their approach based on different stakeholder needs, concerns, or audience member to drive alignment and meet their work goals. • Develop and maintain a strategic territory business plan focused on key academic centers, community targets within priority specialties, territory opportunities and challenges. • Determines and implements suitable travel schedule and call plan on a daily/weekly basis to ensure both adequate and highly effective coverage for all key accounts. • Executes programs, high impact in-services, and other educational opportunities for their territory. • Timely completion of compliance trainings, internal product & disease state trainings, Veeva administration, monthly expense reports, and all other administration expectations.

• Process optimization and execution in providing real world evidence to key stakeholders including patients, providers, researchers, and patient advocacy groups • Ensure evidence strategy alignment throughout the development cycle for a program and across functions • Implement best practices for one or more assigned DMPs to monitor key deliverables (e.g. evidence generation, achievement of goals, financial health) • Provide input on the development of protocols, goals and endpoints tables, case report forms, Integrated Evidence Plans, publications, Steering Committees and other relevant deliverables • Represent the DMP S&M function on the project teams, such as the Development Sub-Team, Core Teams (as applicable), etc. • Train and mentor cross-functional personnel working on DMPs as needed

Title: Director, Chemical (Drug Substance) Manufacturing Management Location: Brisbane, CA Job 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. 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: ultrafocused – Work together to fearlessly uncover new possibilities The Director, Drug Substance Manufacturing provides technical and operational leadership for drug substance manufacturing activities supporting Ultragenyx’s small molecule and oligonucleotide programs. This role is responsible for execution of departmental manufacturing strategies, management of external CMOs, and delivery of reliable clinical and commercial supply under cGMP conditions. The Director partners cross‑functionally to ensure safe, compliant, and efficient manufacturing while operating within established functional strategies. Work Model: Flex: This role will typically require onsite work 2-3 days each week or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities: - Lead and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment, supporting both clinical and commercial supply. - Oversee production planning, execution, and performance tracking to ensure reliable fulfillment of agreed manufacturing services. - Manage and strengthen CMO relationships, including selection, onboarding, governance, and ongoing performance management. - Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio, ensuring alignment with development and supply strategies. - Author and/or provide expert input into CMC sections for global regulatory filings, including INDs, IMPDs, NDAs, and MAAs. - Serve as an integral member of cross‑functional and cross‑discipline CMC teams for programs containing synthetic components. - Oversee process development, optimization, technology transfer, and lifecycle management, including change controls, deviations, and investigations. - Ensure development and maintenance of manufacturing-related documentation, including Design History Files and Quality Risk Management Plans. - Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing and quality governance documents. - Promote continuous improvement, knowledge management, and operational excellence while representing Drug Substance Manufacturing on global and cross‑functional teams. Requirements: - Ph.D. in chemistry, chemical engineering, organic chemistry, or a related discipline, or equivalent industry experience. - 8–12 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing. - Demonstrated experience in managing small molecule synthetic chemistry, pharmaceutical CMC development, process scale‑up, and cGMP manufacturing. - Demonstrated experience managing and participating in cross‑functional CMC teams. - Strong background in development and clinical manufacturing of small molecule drug substances; experience with oligonucleotides is a plus. - Familiarity with QbD principles, DoE, process scale-up and optimization, validation/qualification, and phase‑appropriate controls. - Solid knowledge of cGMP requirements, ICH guidelines, and phase‑appropriate controls.. - Familiarity with analytical development and quality control is advantageous. - Strong track record of building and sustaining effective CMO partnerships. - Demonstrated ability to lead teams, manage complexity, and deliver results in a matrixed environment. - Excellent written and verbal communication skills in English; additional languages are a plus. - Demonstrated commitment to leadership development, coaching, and continuous learning. Physical Demand Requirements Office‑based role with occasional presence in manufacturing and partner facilities. requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body may be required during site visits or when attending as person-in-plant. This requires the ability to change clothes into appropriate gowning and personal protective equipment. #LI-CT1 #LI-Hybrid 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 $212,800—$262,800 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. See our CCPA Employee and Applicant Privacy Notice. See our Privacy Policy. 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.