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As a leader within Ultragenyx, the Regulatory Affairs Sr. Director, Global Labeling, will leverage broad knowledge and expertise to lead the function within Global Regulatory Affairs. In this position, the individual will be responsible for developing and executing the overall labeling strategy for products in development through commercialization. S/he will oversee and/or manage the development, review and approval of all labeling components including draft labeling text to support marketing applications, final package inserts, labels and company core data sheets (CCDS). The individual must possess a thorough knowledge of global regulations for labeling and strong communication and project management skills. The Sr. Director, Global Labeling will manage, mentor and develop a team of Global Regulatory Labeling partners.
Remote: Officially documented as working full-time from home, with travel to Ultragenyx’s offices or other locations on occasion as needed.
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.
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