Remote Senior Director

Summary

Join Ultragenyx, a biopharma company that leads the future of rare disease medicine, and be part of an organization where you can have a meaningful impact, do the best work of your career, and grow both professionally and personally. As a Regulatory Affairs Sr. Director, Global Labeling, you will lead the Global Labeling function for Ultragenyx, oversee the labeling process, and ensure compliance with US and EU regulatory requirements.

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

Responsibilities

• 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

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