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:

Ultragenyx is seeking a highly motivated Senior Director, Regulatory Affairs CMC, who is a team builder and enjoys a fast-paced, dynamic work environment. In this position, the SDIR will be responsible for developing, implementing, and advising on global CMC regulatory strategies for all development-stage programs and marketed products to secure and maintain market access for the products in line with business objectives, and in coordination with key internal and external stakeholders. This individual will provide leadership, high level strategic and operational regulatory direction and mentorship on projects including, but not limited to CMC regulatory strategies, CMC regulatory requirements for development programs and commercial products in domestic and global markets, CMC regulatory strategic development plans and risk assessments, critical issues management and Health Authority interactions while ensuring that the most current requirements, standards, and trends within the company and industry are met. The individual has departmental and corporate level influence and acts as an advisor/liaison to senior management to plan, evaluate and recommend CMC regulatory strategy. Externally, the individual will interface with global regulatory agencies and business partners with regards to technical development, CMC regulatory, registration, and life-cycle management strategies. He/she will support/lead the development and implementation of department policies. The individual will maintain awareness of the global regulatory environment and assess and communicate the impact of changes on business, development programs, and commercial products. This position will report to the Vice-President of Regulatory Affairs CMC