Senior Director, Global Regulatory Affairs – Labeling

📋 Description

• Lead the Global Labeling function at Ultragenyx, acting as an internal authority on health agency regulations and guidelines.

• Responsible for overseeing the labeling process for all development programs through to commercialization at Ultragenyx.

• Provide strategic and operational leadership in alignment with business objectives, regulations, and guidelines.

• Guide, develop, and draft labeling text (e.g., USPI, PPI, MedGuide, EU SmPC, EU PIL) to facilitate marketing applications and updates of approved package inserts, supporting product lifecycle management.

• Ensure the labeling strategy aligns with the overall regulatory strategy and program objectives by collaborating closely with the regulatory head, strategy lead, and development and project teams.

• Verify that labeling complies with US and EU regulatory requirements.

• Develop and maintain the Company Core Data Sheet (CCDS).

• Provide strategic regulatory guidance and expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance across global portfolios.

• Lead the process to secure labeling approval from Senior Management, fostering cross-functional collaboration and ensuring alignment of the labeling strategy and content at all levels.

• Capable of leading, managing, motivating, mentoring, and developing a diverse team of Global Labeling Strategy Leads responsible for creating, reviewing, and finalizing labeling across all development programs through commercialization.

• Skilled in leading, managing, motivating, and developing Global Labeling Operations Leads responsible for overseeing packaging and artwork strategies throughout all commercial product lifecycles.

⛳️ Requirements

• Preferred BSc Degree; an advanced scientific degree (MSc, PhD, or PharmD) is a plus.

• At least 12 years of experience in the biotechnology or pharmaceutical industry, with considerable global labeling experience.

• Significant pharmaceutical background with emphasis on regulatory matters and both development and post-marketing phases in the US and EU.

• Strong understanding of global labeling processes and their implications across the organization.

• Ability to leverage past experiences to devise innovative and adaptable approaches for achieving commercial objectives.

• Effective decision-making skills, even in ambiguous situations, following appropriate consultation.

• Excellent writing skills, capable of processing scientific data and summarizing it effectively for labeling content.

• Strong oral and written communication skills, negotiation abilities, integrity, and adaptability.

• Demonstrated leadership skills, with the capacity to inspire colleagues and influence within a matrixed organization.

• Collaborative mindset with a focus on working towards solutions.

• Exceptional teamwork and interpersonal skills, both internally and externally.

• Strategic thinker who is open-minded and flexible in embracing new and creative ideas.

• Willingness to thrive in a dynamic and evolving corporate environment.

• Experience with rare diseases is desirable.

🏝️ Benefits

• Generous vacation time and public holidays recognized by the company.

• Volunteer days.

• Long-term incentives and employee stock purchase plans or equivalent offerings.

• Employee wellbeing benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.