Associate Director, Regulatory Operations, EMEA

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:** ***ultra**curious – Apply your biggest ideas in courageous ways* At Ultragenyx, Regulatory Operations is more than publishing and submissions. If you're looking for a role focused solely on compiling documents and managing timelines, this isn’t it. We are seeking an Associate Director, Regulatory Operations (EMEA) who thrives in a highly collaborative environment, influences outcomes across functions, solves complex challenges, and is passionate about delivering high-quality regulatory submissions to health authorities worldwide. This role offers the opportunity to lead complex regulatory submissions from planning through health authority delivery, combining hands-on expertise in submission management and publishing with strong cross-functional engagement and leadership. As a key member of the Regulatory Operations team, you'll collaborate closely with Global Regulatory Operations, Global Regulatory Affairs, and stakeholders across the organization to drive submission excellence, operational consistency, and regulatory compliance. As the regulatory landscape continues to evolve toward data-driven submissions, advanced metadata management, eCTD 4.0, and IDMP/SPOR, we're looking for a forward-thinking professional ready to help lead the transformation. If you're energized by technology, process optimization, and global collaboration, we'd love to hear from you. ### **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 end-to-end regulatory submission planning and execution for assigned programs, serving as the primary operational lead within EMEA Regulatory Operations and partnering with EMEA Regulatory Affairs, Regulatory Project Management, Global Regulatory Operations, cross-functional stakeholders, and vendors to ensure successful submission delivery. - Develop and execute submission publishing strategies, timelines, milestones, content plans, and delivery plans while proactively managing risks, dependencies, resources, and critical path activities. - Perform and/or oversee publishing activities as required, including document and report preparation, compilation, bookmarking, hyperlinking, metadata verification, technical quality control, validation, and electronic submission transmission. - Ensure regulatory documentation, data, and submission activities are accurate, complete, inspection-ready, and aligned with regional/local requirements by complying with Veeva document management and RIM processes, maintaining data integrity, and end-to-end submission visibility. - Build trusted partnerships across EMEA Regulatory Affairs, Global Regulatory Operations, and key stakeholders to drive aligned ways of working, support execution of global regulatory strategies, and influence operational priorities in support of broader regulatory and business objectives. - Serve as a catalyst for transformation by bridging current-state and future-state Regulatory Operations capabilities, building alignment around a shared vision, identifying and implementing scalable solutions to complex challenges, and driving sustainable improvements that address root causes and prevent recurring issues. - Support Global Regulatory Operations initiatives related to submission acceleration, operational excellence, digital enablement, and business transformation through effective communication, change management, training, and stakeholder engagement. - Develop and evolve Regulatory Operations processes, standards, and procedural documentation, including process maps, SOPs, work instructions, and user guidance, ensuring alignment with global regulatory strategies, emerging technologies, and future-state operating models. - By being an active member of the trade association, EUCOPE, monitor evolving regulatory requirements, industry trends, and digital health authority initiatives, including eCTD 4.0, IDMP/SPOR, structured content, metadata governance, and next-generation submission models, to prepare the organization for successful adoption of new regulatory requirements, technologies, and ways of working. ### **Requirements:** - Bachelor's degree in a scientific, technical, or related discipline, or an equivalent combination of education and relevant experience. - Minimum of 8 years of Regulatory Operations experience within the pharmaceutical, biotechnology, or related life sciences industry. - Extensive knowledge of global regulatory submission requirements, formats, processes, standards, specifications, and health authority expectations. - Demonstrated ability to operate as both a Submission Manager and Publisher across complex global regulatory submissions. - Prioritize organizational success over individual objectives by fostering collaboration, sharing knowledge, supporting colleagues, and contributing to shared Regulatory Affairs goals. - Strong communication, stakeholder engagement, and project leadership skills with the ability to influence, collaborate, and drive alignment across functions and organizational levels. - Exceptional attention to detail, critical thinking, and problem-solving skills, with a demonstrated commitment to quality and compliance. - Working knowledge of EMA submission and data portals as well as emerging regulatory data and submission standards, including IDMP, SPOR, and associated data governance principles. - Experience with Regulatory Operations technologies, including Veeva Vault RIM, Lorenz DocuBridge, StartingPoint Templates, DXC Toolbox, Adobe Acrobat Professional, SharePoint, Smartsheet, AI-enabled solutions, or comparable platforms/tools. - Demonstrated leadership in process improvement, business transformation, digital enablement, or technology implementation initiatives within Regulatory Operations. - Experience thriving in a fast-changing, agile small-company environment, with the ability to navigate ambiguity and balance strategic thinking with hands-on execution. - Experience with eCTD 4.0 submissions, pilot programs, testing initiatives, implementation activities, or transition planning is highly desirable. **#LI-CT1 #LI-Hybrid** ***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**](mailto:talentacquisition@ultragenyx.com)**.** *See our*[*CCPA Employee and Applicant Privacy Notice*](https://www.ultragenyx.com/CCPA-Notice/)*.* *See our*[Privacy Policy](https://www.ultragenyx.com/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. Inquiries on developing a recruiting relationship with us, may be directed to*:*[talentacquisition@ultragenyx.com](http://mailto:talentacquisition@ultragenyx.com/)*.*