Associate Director, Regulatory Affairs, EMEA

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 Ultragenyx is seeking an experienced and highly motivated Associate Director, Regulatory Affairs (Clinical/Nonclinical Strategy), EMEA who is a team play er and enjoys a fast paced, dynamic work environment. The Associate Director will be responsible for developing key EMEA regulatory strategies and executing submissions while monitoring and assessing EMEA regulations including G ene T herapy guidance and regulation changes. This position will report to the Senior Director Regulatory Affairs EMEA . Work Model: Flex: This role will typically require onsite work 2 days each week, depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite. Responsibilities: Interfaces with EMEA regulatory agencies as appropriate on select programs. Independently research options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership. Represent EMEA Regulatory in sub team meetings, serving as the point of contact for the assigned products in the EMEA region, and interfacing with functional areas including Research, Development and Clinical in strategic development for early and late-stage products. Provide regulatory guidance for the EMEA region and input throughout product development to the regulatory sub team. Lead cross functional teams in EMEA Regulatory Filings (e.g. CTAs, GMOs, MAAs) Lead selects Regulatory vendor meetings in alignment with product programs and Regulatory-driven projects Maintain CTAs ensuring Agency compliance Review clinical documentation, including protocols, DSUR’s, Investigator Brochures, Investigator Packages and General Investigational Plans to ensure GCP and Agency compliance Lead teams in the development of briefing documents for EMEA Agency meetings Manage and direct contractors/vendors as needed on programs Keep current with EMEA Agency guidelines and regulations Prepare comments on draft documentation sent out for consultation from the health authority Contribute to creation of local labels as needed Coordinate submission schedule with Publishing, ensuring delivery of high-quality documents Participate on cross-functional committees and sub-teams in accordance with company initiatives, as necessary Provides supervision and mentoring to junior regulatory professionals on the team, if applicable Requirements: BA/BS in a scientific field of study or BA/BS in another field of study and 8 years of relevant experience working in Regulatory in the pharmaceutical/ biotech in ... (truncated, view full listing at source)