Associate Director, Regulatory Operations, EMEA

ultracurious Apply your biggest ideas in courageous ways

At Ultragenyx Regulatory Operations is more than publishing and submissions. If youre looking for a role focused solely on compiling documents and managing timelines this isnt 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 youll 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 were looking for a forward-thinking professional ready to help lead the transformation. If youre energized by technology process optimization and global collaboration wed love to hear from you.

Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.

• 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.

• Bachelors 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