Sr. Director, Global Regulatory Affairs Labeling

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:

ultrafocused – Work together to fearlessly uncover new possibilities

As a leader within Ultragenyx, the Sr. Director, Global Regulatory Affairs 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 and leading the labeling operations function. S/he will oversee and/or manage the development, review and approval of all labeling components (company core data sheets (CCDS), prescribing information, final package inserts, labels, packaging & artwork) including drafting the labeling text to support marketing applications. The individual must possess a thorough knowledge of global regulations for labeling and strong communication, collaboration and project management skills. The Sr. Director, Global Regulatory Affairs Labeling will manage, mentor and develop a team of Global Regulatory Labeling Strategy Leads and Global Labeling Operations Leads.

Work Model: 

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Lead the Global Labeling function for Ultragenyx and serve as an internal expert on health agency regulations and guidelines.

2. Accountable for oversight of the labeling process at Ultragenyx for all programs in development through commercialization.

3. Provide strategic and operational leadership in accordance with business goals and objectives, regulations, and guidelines.

4. 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.

5. 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.

6. Confirm labeling is compliant with US and EU regulatory requirements.

7. Develop and maintain CCDS.

8. Provides strategic regulatory guidance and expert advice on current labeling requirements, templates, tools and Health Authority-issued guidance across the portfolios globally.

9. 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.

10. Ability to lead, manage, motivate, mentor and develop a diverse team of Global Labeling Strategy Leads accountable for developing and reviewing and finalizing labeling across all development programs through commercialization.

11. Ability to lead, manage, motivate and develop Global Labeling Operations Leads accountable for overseeing packaging and artwork strategies across all commercial product lifecycles.

Requirements:

1. BSc Degree preferred and advanced scientific degree (MSc, PhD, or PharmD) a plus.

2. A minimum of 12 years’ experience in the biotechnology or pharmaceutical industry with extensive global labeling experience.

3. Significant pharmaceutical background with focus on regulatory and/or both development and post-marketing phases in the US and EU.

4. Strong understanding of global labeling processe