Associate Director, Global Regulatory Affairs – Labeling

📋 Description

• Provides global leadership in labeling to support the development, registration, and life-cycle management of Ultragenyx products aimed at rare diseases.

• Develops and revises labeling content (including Company Core Data Sheet, Prescribing Information, Summary of Product Characteristics, Major Market labels, Patient Information, and Instructions for Use) based on source reports, regulatory requirements, and additional reference materials.

• Exhibits the capability to operate within a matrix environment by communicating label concepts and essential messaging during label development that aligns with program strategy, while also understanding and educating on the implications for downstream activities (such as commercial and promotional educational purposes).

• Establishes strong collaboration with key internal stakeholders, including the Global Regulatory leadership team, Clinical Development, Safety, Quality, Commercial, Medical Affairs, Legal, Manufacturing, Supply Chain, and other departments to support the creation of draft label text.

• Engages with the cross-functional labeling team (Label Working Group and Label Review Committee) to ensure the prompt implementation of global labeling changes in local product information that align with the company’s defined position in the CCDS and comply with local labeling regulations.

• Prepares, manages, and/or delivers various regulatory documents/submissions, influencing and coordinating cross-functional team input to ensure high-quality deliverables that meet regulatory standards and corporate and program milestones. Facilitates meetings for LWG/LRC/SME to develop content for label documents, including the resolution of complex labeling issues and the ability to achieve consensus using current standard operating procedures, best practices, and/or work instructions, including work requests related to partner companies and vendors.

• Leads and facilitates target label strategies with the cross-functional labeling team, incorporating key messaging that aligns with the target product profile and demonstrating a comprehensive understanding of the competitive landscape. Provides necessary label output for health authority interactions (such as FDA/EMA/PMDA/HC briefing books, scientific advice, and/or other key submission readiness milestones).

• Maintains approved labels within a document label management system to ensure that accurate and up-to-date labeling is consistently available and accessible for global submissions and inspection readiness.

• Contributes to the review and approval of artwork supporting global submissions.

• Implements and maintains quality control measures throughout all stages of label development.

• Keeps abreast of current global rules, regulations, and relevant guidance (draft or final) governing drugs and biologics in all phases of development, along with knowledge of therapeutic areas.

• Initiates or contributes to local and/or global process and/or system improvements that significantly impact the business.

⛳️ Requirements

• A minimum of a BA/BS degree in life sciences; an advanced degree is preferred.

• Strong scientific background with at least 8 years of experience in the biotechnology and/or pharmaceutical industry, including a minimum of 4 years in a global regulatory/labeling role.

• Exceptional attention to detail with robust coordinating, task planning, and time management abilities.

• Excellent verbal, written, and interpersonal communication skills.

• Capable of working independently as well as part of a team, demonstrating strong leadership, negotiation, and influencing skills.

• A strategic thinker and problem-solver with the ability to provide advice, identify risks, make decisions collaboratively, and implement plans and risk mitigation strategies.

• Comprehensive understanding of global drug development regulations and guidelines.

• Willingness to thrive in a dynamic, fast-paced, and evolving corporate environment where roles and responsibilities may not be clearly defined.

🏝️ Benefits

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

• Volunteer days.

• Long-term incentive and Employee stock purchase plans or equivalent offerings.

• Employee well-being benefits.

• Fitness reimbursement.

• Tuition sponsorship.

• Professional development plans.