Associate Director, Regulatory Affairs CMC Japan

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 focused – Work together to fearlessly uncover new possibilities The Associate Director of R egulatory CMC will lead and execute related chemistry, manufacturing and controls (CMC) regulatory activities/interactions under overall direction of Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC , and will help to develop regional regulatory CMC strategies for both established products and development products , serving as a key operational interface with global and regional teams. 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: Contribute to the development and execution of the CMC regulatory strategies and lead day-to-day management of related regulatory activities for assigned programs. Under the guidance of the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, work with global and regional teams to develop and maintain project plans and timelines for pipeline of products, including coordination and support of global regulatory CMC submissions. Provide functional supervision and guidance to team members to ensure that all reporting requirements and other commitments are met with respect to Clinical Trial Notifications (CTN), NDAs, PCAs, MCNs, etc. while escalating issues and risks to the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC, as appropriate. Provide regulatory advice and support for the global regulatory compliance of Ultragenyx pipeline of products including the evaluation of CMC related change controls, the strategic assessment of process and product comparability, their regulatory impact and implementation , with escalation of key risks and issues to the Head of Regulatory Affairs Japan and/or VP, Global Regulatory CMC as appropriate. Coordinate the preparation, review and filing of CMC sections of regulatory submissions and support interactions with regional regulatory agencies. Coordinate and oversee the preparation of regulatory CMC submission documentation to ensure that it is prepared with appropriate quality and within agreed timelines, in order to meet regional regulatory requirements and corporate objectives. Maintain and manage a centralized archive for tracking and monitoring the status of regulatory CMC commitments and agency reporting obligations, and prepare, generate and communicate status reports and other communication to the organization. Provide strategic and technical CMC regulatory support, guidance ... (truncated, view full listing at source)