Ultragenyx Pharmaceutical Inc.

FullTime

<div><div style="padding: 0; margin: 15px 0 15px 0"><p><strong>Description</p></strong><p style="padding: 0; margin: 15px 0 15px 0"><div style="padding: 0; margin: 15px 0 15px 0"><div style="padding: 0; margin: 15px 0 15px 0"><strong> Why Join Us? </strong></div><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"><em> Be a hero for our rare disease patients </em></div><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"> 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. </div><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"> 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. </div><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"> 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 <em> . </em></div></div><div style="padding: 0; margin: 15px 0 15px 0"><strong> Position Summary: </strong></div><p style="padding: 0; margin: 15px 0 15px 0"><em><strong> ultra </strong> innovative – Tackle rare and dynamic challenges </em></p><p style="padding: 0; margin: 15px 0 15px 0"> 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. </p><div style="padding: 0; margin: 15px 0 15px 0"><strong> Work Model: </strong></div><p style="padding: 0; margin: 15px 0 15px 0"> Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. </p><p style="padding: 0; margin: 15px 0 15px 0"></p><div style="padding: 0; margin: 15px 0 15px 0"><strong> Responsibilities: </strong></div><ul style="margin: 15px 0 15px 0; padding: 0 0 0 20px"><li style="margin-bottom: 5px"> Lead the Global Labeling function for Ultragenyx and serve as an internal expert on health agency regulations and guidelines. </li><li style="margin-bottom: 5px"> Accountable for oversight of the labeling process at Ultragenyx for all programs in development through commercialization </li><li style="margin-bottom: 5px"> Provide strategic and operational leadership in accordance with business goals and objectives, regulations, and guidelines. </li><li style="margin-bottom: 5px"> Guide, develop and author draft labeling text (e.g., USPI, PPI, MedGuide, EU SmPC, EU PIL) to support marketing applications and labeling updates of approved package inserts to support product lifecycle management. </li><li style="margin-bottom: 5px"> Ensure labeling strategy is aligned with overall regulatory and program strategy by working closely with the regulatory head, strategy lead and development and project teams. </li><li style="margin-bottom: 5px"> Confirm labeling is compliant with US and EU regulatory requirements. </li><li style="margin-bottom: 5px"> Develop and maintain CCDS. </li><li style="margin-bottom: 5px"> Provides strategic regulatory guidance and expert advice on current labeling requirements, Templates, tools and Health Authority-issued guidance across the portfolios globally </li><li style="margin-bottom: 5px"> Chairs the process to obtain labeling approval by Senior Management providing leadership to foster cross-functional collaboration and drive alignment of the labeling strategy and labeling content at all levels </li><li style="margin-bottom: 5px"> Ability to lead, manage, motivate, mentor and develop a diverse team of Global Labeling Leads accountable for developing and reviewing and finalizing of labeling across all development programs through commercialization </li></ul><div style="padding: 0; margin: 15px 0 15px 0"><strong> Requirements: </strong></div><ul style="margin: 15px 0 15px 0; padding: 0 0 0 20px"><li style="margin-bottom: 5px"> BSc Degree preferred and advanced scientific degree (MSc, PhD, or PharmD) a plus </li><li style="margin-bottom: 5px"> A minimum of 10 years experience in the biotechnology or pharmaceutical industry with extensive global labeling experience. </li><li style="margin-bottom: 5px"> Significant pharmaceutical background with focus on Regulatory and/or both development and post-marketing phases in the US and EU </li><li style="margin-bottom: 5px"> Strong understanding of global labeling processes, and implications across the organization </li><li style="margin-bottom: 5px"> Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals </li><li style="margin-bottom: 5px"> Crisp decision making following appropriate consultation, even in times of ambiguity </li><li style="margin-bottom: 5px"> Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content. </li><li style="margin-bottom: 5px"> Strong oral and written communication skills, negotiation skills, integrity and adaptability </li><li style="margin-bottom: 5px"> Demonstrate leadership skills and ability to inspire colleagues and influence in a matrixed organization </li><li style="margin-bottom: 5px"> Excellent teamwork and interpersonal skills, both internally and externally. </li><li style="margin-bottom: 5px"> Strategic thinker, open-minded and flexible to adopting new ideas. </li><li style="margin-bottom: 5px"> Willingness to work in a dynamic and changing corporate environment. </li><li style="margin-bottom: 5px"> Rare disease experience is desirable. <span><em> #LI-CS1 </em><em><span> #LI-Remote </span></em></span></li></ul><div style="padding: 0; margin: 15px 0 15px 0"><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> Full Time employees across the globe enjoy a range of benefits, including, but not limited to: </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> · Generous vacation time and public holidays observed by the company </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> · Volunteer days </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> · Long term incentive and Employee stock purchase plans or equivalent offerings </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> · Employee wellbeing benefits </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> · Fitness reimbursement </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> · Tuition sponsoring </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"><strong><em> · Professional development plans </em></strong></div><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"><em> * Benefits vary by region and country </em></div><div style="padding: 0; margin: 15px 0 15px 0"><p style="padding: 0; margin: 15px 0 15px 0"><strong> 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 </strong><a href="%22mailto:talentacquisition@ultragenyx.com%22" rel="nofollow"><strong> talentacquisition@ultragenyx.com </strong></a><strong> . </strong></p></div><div style="padding: 0; margin: 15px 0 15px 0"><em> See our </em><a href="%22https://www.ultragenyx.com/CCPA-Notice/%22" rel="nofollow"><em> CCPA Employee and Applicant Privacy Notice </em></a><em> . </em></div><div style="padding: 0; margin: 15px 0 15px 0"><em> See our </em><a href="%22https://www.ultragenyx.com/privacy-policy/%22" rel="nofollow"> Privacy Policy </a><em> . </em></div><div style="padding: 0; margin: 15px 0 15px 0"></div><div style="padding: 0; margin: 15px 0 15px 0"><strong> Note to External Recruiters </strong> : All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to <em> : </em><a href="%22http://mailto:talentacquisition@ultragenyx.com/%22" rel="nofollow"> talentacquisition@ultragenyx.com </a><em> . </em></div></div></p></div></div>

Ultragenyx Pharmaceutical Inc.

Senior Director, Global Regulatory Affairs Labeling

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