Sr. Director, Global Regulatory Affairs Labeling

About the Role

The Sr. Director will work closely with the regulatory head, strategy lead, and development teams to ensure that the labeling strategy is aligned with the overall regulatory and program strategy. This role requires a deep understanding of global regulations for labeling, as well as strong communication, collaboration, and project management skills. As a leader, you will be responsible for managing, mentoring, and developing a team of Global Regulatory Labeling Strategy Leads and Global Labeling Operations Leads.

Ultragenyx is committed to creating a supportive and inclusive work environment, where employees can thrive in all areas of their lives. As a remote worker, you will have the flexibility to work from home, with occasional travel to Ultragenyx's offices or other locations as needed.

What You Will Do

• Lead the Global Labeling function for Ultragenyx and serve as an internal expert on health agency regulations and guidelines.
• Oversee the labeling process 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 to support marketing applications and labeling updates of approved package inserts.
• Ensure labeling strategy is aligned with overall regulatory and program strategy.
• Confirm labeling is compliant with US and EU regulatory requirements.
• Develop and maintain Company Core Data Sheets (CCDS).
• Provide strategic regulatory guidance and expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance.
• Chair 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.
• Lead, manage, motivate, mentor, and develop a diverse team of Global Labeling Strategy Leads.

What We Are Looking For

• 10+ years of experience in regulatory affairs, with a focus on labeling.
• Strong knowledge of global regulations for labeling, including US and EU requirements.
• Proven leadership skills, with the ability to manage and develop teams.
• Excellent communication, collaboration, and project management skills.
• Experience with labeling operations, including the development and review of labeling text.
• Strong analytical and problem-solving skills, with the ability to think strategically.
• Experience with Adjust and Excel, as well as other regulatory software and tools.
• Ability to work in a fast-paced environment, with a focus on rapid development and commercialization.

Nice to Have

• Experience with rare disease treatments, particularly in the biopharma industry.
• Knowledge of novel rapid development approaches and their application in regulatory affairs.
• Familiarity with Health Authority-issued guidance and regulations, including FDA and EMA guidelines.
• Experience with cross-functional collaboration, including work with development and project teams.

Benefits and Perks

• Competitive salary and benefits package.
• Opportunity to work on groundbreaking rare disease treatments.
• Collaborative and inclusive work environment, with a focus on employee growth and development.
• Flexible remote work arrangement, with occasional travel to Ultragenyx's offices or other locations.
• Access to cutting-edge technology and regulatory software.
• Professional development opportunities, including training and education programs.
• Recognition and reward programs, including bonuses and stock options.

• Develop a strong understanding of global regulations for labeling, including US and EU requirements, to increase your chances of success in this role.
• Showcase your leadership skills by highlighting examples of team management and development in your application and during interviews.
• Familiarize yourself with Adjust and Excel, as well as other regulatory software and tools, to demonstrate your technical expertise.
• Prepare to discuss your experience with labeling operations, including the development and review of labeling text, and your ability to think strategically.
• Be ready to provide examples of your ability to work in a fast-paced environment, with a focus on rapid development and commercialization.
• Research Ultragenyx's commitment to rare disease treatments and its approach to regulatory affairs to demonstrate your passion for the industry and the company.
• Highlight your skills in cross-functional collaboration, including work with development and project teams, to demonstrate your ability to work effectively with others.