Senior Director - Global Regulatory Affairs Labeling

October 6

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Ultragenyx

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rare disease • ultra-rare disease

501 - 1000

Description

• Be a hero for our rare disease patients • Lead the Global Labeling function for Ultragenyx and serve as an internal expert on health agency regulations and guidelines. • Accountable for oversight of the labeling process at Ultragenyx for all programs in development through commercialization • Provide strategic and operational leadership in accordance with business goals and objectives, regulations, and guidelines. • 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. • 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. • Confirm labeling is compliant with US and EU regulatory requirements. • Develop and maintain CCDS. • Provides strategic regulatory guidance and expert advice on current labeling requirements, Templates, tools and Health Authority-issued guidance across the portfolios globally • 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 • 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

Requirements

• BSc Degree preferred and advanced scientific degree (MSc, PhD, or PharmD) a plus • A minimum of 10 years experience in the biotechnology or pharmaceutical industry with extensive global labeling experience. • Significant pharmaceutical background with focus on Regulatory and/or both development and post-marketing phases in the US and EU • Strong understanding of global labeling processes, and implications across the organization • Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals • Crisp decision making following appropriate consultation, even in times of ambiguity • Strong writing skills; able to process scientific data and effectively summarize into the appropriate detail for labeling content. • Strong oral and written communication skills, negotiation skills, integrity and adaptability • Demonstrate leadership skills and ability to inspire colleagues and influence in a matrixed organization • Excellent teamwork and interpersonal skills, both internally and externally. • Strategic thinker, open-minded and flexible to adopting new ideas. • Willingness to work in a dynamic and changing corporate environment. • Rare disease experience is desirable.

Benefits

• Generous vacation time and public holidays observed by the company • Volunteer days • Long term incentive and Employee stock purchase plans or equivalent offerings • Employee wellbeing benefits • Fitness reimbursement • Tuition sponsoring • Professional development plans