Sr. Director, Global Regulatory Affairs Labeling

The Sr. Director, Global Regulatory Affairs Labeling at Ultragenyx is responsible for leading the global labeling strategy and operations for products in development through commercialization, ensuring compliance with regulations, and managing a team of labeling strategy and operations leads.

Location: Remote

Salary: $243,800—$301,100 USD per year

Responsibilities

• Lead the Global Labeling function and serve as an internal expert on health agency regulations and guidelines.
• Oversee the labeling process for all programs from development through commercialization.
• Provide strategic and operational leadership aligned with business goals, regulations, and guidelines.
• Guide, develop, and author draft labeling texts to support marketing applications and lifecycle management.
• Ensure labeling strategy aligns with regulatory and program strategies.
• Confirm labeling compliance with US and EU regulatory requirements.
• Develop and maintain Company Core Data Sheets (CCDS).
• Provide strategic regulatory guidance on labeling requirements and guidelines globally.
• Chair the process for labeling approval by Senior Management, fostering cross-functional collaboration.
• Lead, manage, motivate, mentor, and develop a team of labeling strategy and operations leads.

Requirements

• BSc Degree preferred, advanced scientific degree (MSc, PhD, or PharmD) a plus.
• Minimum of 12 years’ experience in the biotechnology or pharmaceutical industry with extensive global labeling experience.
• Significant pharmaceutical background with focus on regulatory and/or development and post-marketing phases in the US and EU.
• Strong understanding of global labeling processes and implications.
• Ability to develop innovative approaches to achieve commercial goals.
• Decisiveness and ability to work in ambiguity.
• Strong scientific writing skills.
• Excellent communication, negotiation, and interpersonal skills.
• Leadership skills and ability to influence in a matrixed organization.
• Collaborative mindset and solution-oriented approach.
• Willingness to work in a dynamic environment.
• Experience in rare diseases is desirable.

Benefits

• Generous vacation time and public holidays.
• Volunteer days.
• Long-term incentive and employee stock purchase plans.
• Employee wellbeing benefits.
• Fitness reimbursement.
• Tuition sponsorship.
• Professional development plans.

Additional Information

• The position is full-time, remote with occasional travel.
• Salary range: $243,800—$301,100 USD annually, plus bonus and equity incentives.
• Ultragenyx is an equal opportunity employer and provides reasonable accommodations for applicants with disabilities and other protected statuses.